Spoke to a Vicore analyst today.

The appointment of the new US-based CEO by VIcore is a big thing. If listed in the US, Vicore would be trading at a 10 times higher valuation than today. THe US-based CEO will connect Vicore to the US investors. Material upside in my view:

Full investment thesis + interviews with analysts:
https://fitinvestmentideas.com/2023/09/16/seekingalpha-vicore-pharma-is-leading-the-race-in-ipf-cure/

Link to Vicore´s presentation at the Stifel conference

Vicore has hired a new US-based CEO.

If Vicore were a US-listed company, its valuation would be multiple times higher. The best proof is Pliant, a company in a similar state of development with much worse drug results.

The new Vicore CEO is now starting to talk to US investors. He has a strong investment proposition - no other drug ever had so strong results in IPF.

He attended last week's Stifel conference. The link to his presentation is below, and the PDF presentation is on their www:

https://wsw.com/webcast/stifel83/vico/2098546

Update on Vicore Stifel conference:

Vicore – New US-Based CEO Starts Onboarding US Investors

If Vicore were a US-listed company, its valuation would be multiple times higher. The best proof is Pliant, a company in a similar state of development with much worse drug results. Vicore hired a new Boston-based CEO whose claim is to connect Vicore to a US investor base.

https://fitinvestmentideas.com/2023/11/20/vicore-new-us-based-ceo-starts-onboarding-us-investors/

Stifel conference replay - first big US event for the new Boston-Based Vicore CEO

The share has been rising since:

The replay:
https://wsw.com/webcast/stifel83/vico/2098546

PDF version of the Stifel NY conference from the last week:

https://vicorepharma.com/wp-content/uploads/2023/11/vicore-pharma-corporate-presentation-november-2023-1.pdf

VIcore up every day since last week's Stefel conference. US investors coming in?

Vicore to Present at the 2023 DNB Nordic Healthcare Conference
Stockholm, December 11, 2023 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced that Ahmed Mousa, Chief Executive Officer, will present at the 2023 DNB Nordic Healthcare Conference in Oslo, Norway.

Details of the presentation are as follows:

Date and Time: December 14 at 15:10 CET
Place: DNB – Dronning Eufemias gate 30, Oslo, Norway

For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437 0235, ahmed.mousa@vicorepharma.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

This information was submitted for publication on December 11 at 09:00 CET.

About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs to stop disease progression and restore function. The company is establishing a portfolio in rare lung diseases including idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in a phase 2a study of IPF. C21 is protected by US and European orphan drug designation. A variety of patents have been filed to provide further protection for C21, out to 2040 and onwards. Almee™ (an investigational medical device in clinical development) is a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) created to address the psychological impact of living with pulmonary fibrosis. Inhaled IMID is a new formulation and delivery route of thalidomide targeting the severe cough associated with IPF. Using its unique expertise in the ATRAG biology Vicore is further fueling its pipeline with several new small molecule drug assets, with long patent life and for a variety of indications, some of which could be partnered while others may be taken to the market by Vicore. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

The presentation is available on their web site

LInk to the presentation at the Stfel conference:

https://wsw.com/webcast/stifel83/vico/2098546

Vicore Pharma AB on Linked just now:

Our CEO, Ahmed Mousa, was recently featured on the Optimum Perspectives Podcast! In a conversation with Richard Staines, he delved into Vicore Pharma AB strategy for improving treatments for Idiopathic Pulmonary Fibrosis (#IPF) patients. This included insights into our upcoming phase 2b 'ASPIRE' trial, scheduled to commence first half next year.

Listen here and learn more about our commitment to revolutionize the landscape of IPF treatment: https://lnkd.in/dZWYypZM

https://lnkd.in/dZWYypZM

Har fulgt med på Vicore i noen år allerede og eid den i perioder, men holder meg mest på sidelinjen for tidslinjen er for lang pr nå. 2b starter ikke før i H1 2024 (readout for fase 2a er pr nå estimert til mars 2024) og vil vel vare ett år+ i tid. Da snakker vi godt ut i 2025. Og risikoen føles også stor så jeg er generelt skeptisk til å eie før man har en god 2b i mål. Men som et bittelite krydder? Kanskje. Bare husk på risikoen når man ikke har kommet gjennom 2b ennå.

Samme her, var inne tidligere i år men ute nå.
Uaktuelt å gå inn med en større post og vente så lenge frem til en binær readout av 2B.

Tror 2025 readout er optimistisk. Dersom samtlige pasienter blir rekruttert fra dag 1, så vil det ta 52 uker før alle er igjennom, også et par måneder datavask.

2026 er nok mer realitistisk.

Da er jeg heller inne i andre ting med kortsiktige triggers, men den er på watch list. Absolutt

From Vicore´s Linkedin:

Our CEO, Ahmed Mousa, was recently featured on the Optimum Perspectives Podcast! In a conversation with Richard Staines, he delved into Vicore Pharma AB strategy for improving treatments for Idiopathic Pulmonary Fibrosis (#IPF) patients. This included insights into our upcoming phase 2b 'ASPIRE' trial, scheduled to commence first half next year.

Listen here and learn more about our commitment to revolutionising the landscape of IPF treatment: https://lnkd.in/dZWYypZM

Vicore is my top idea for 2024

The company got a new CEO in September. US-based experienced guy with a great CV.

Vicore team is strengthening. "Vicore Pharma AB is pleased to welcome Professor Bertil E. Lindmark MD, PhD, as our new Chief Medical Officer, starting January 1, 2024.

With a wealth of experience in respiratory medicine, Dr. Lindmark, formerly of AstraZeneca and Galecto, is renowned for his leadership in developing top-selling respiratory medications. This strategic move follows the success of our Phase 2a AIR interim data read-out for idiopathic pulmonary fibrosis (#IPF) in May 2023 and underscores our commitment to global leadership in this field."

This is crucial for planning its forthcoming 2b study to be accepted for FDA approval.

As Pareto states - it is a multi-billion dollar company in the making


https://www.linkedin.com/in/professor-bertil-e-lindmark-md-phd-5b661611/

Interview with the new Vicore CEO. Very interesting read:

https://www.biospace.com/article/ahmed-mousa-from-the-hill-to-the-c-suite/

Vicore Confirms IPF Development Program on Track and Provides Early-Stage Pipeline Updates
Development of C21 in IPF on track; final Phase 2a AIR data in first half of 2024 and Phase 2b ASPIRE initiation in first half of 2024
AlmeeTM pivotal study COMPANION completion on-track; topline results expected to be announced this month
Transition to late-stage development of C21 in IPF drives increased focus in pipeline; preclinical IMiD program to be discontinued
Review ongoing for follow-on indications and molecules to complement development of C21 in IPF
Stockholm, January 2, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced pipeline updates as the company continues to focus on development of C21 for idiopathic pulmonary fibrosis (IPF).

The updates announced today include confirmation that development of the lead program, C21 for IPF is on track, with final Phase 2a AIR[1] data in the first half of next year. In addition, start-up activities for the global, double-blind, placebo-controlled, 52-week, Phase 2b ASPIRE study of C21 for IPF are progressing with initiation expected in the first half of 2024. Development of the Almee digital therapy advances as well, with topline results of the COMPANION[2] pivotal study for anxiety associated with pulmonary fibrosis expected to be reported in January 2024.

In its early-stage pipeline, as a result of an on-going portfolio review process that aims to focus investments, Vicore will discontinue development of the preclinical IMiD program, inhaled thalidomide for IPF cough. The review is also expected to select the best possible follow-on indications and ATRAG molecules for further development in view of the unique characteristics of this upstream mechanism of action that drives tissue repair.

“With the strong clinical signal for C21 in IPF demonstrated in its May 2023 Phase 2a interim read out, Vicore is entering a stage of focus on driving this drug candidate through successful development,” said Ahmed Mousa, Chief Executive Officer of Vicore, “with this enhanced prioritization we will discontinue development of the preclinical IMiD program for IPF cough in favor of advancing the potentially transformative therapy C21 for IPF patients.”

“We are extremely committed to successful development of C21 for IPF,” said Bertil Lindmark, MD, PhD, newly appointed Chief Medical Officer of Vicore, “and ensuring allocation of resources to win in this space. We look forward to an impactful disclosure of final Phase 2a AIR data as well as initiating the global Phase 2b ASPIRE study in the first half of 2024.”

“Activation of the angiotensin II type 2 receptor is a potent protective mechanism with strong potential beyond IPF,” said Johan Raud, MD, PhD, Chief Scientific Officer of Vicore, “we are reviewing a number of indications where we believe this pathway can have a disease-modifying effect and pair well with the specific properties of our ATRAG molecules. We look forward to sharing more on our follow-on pipeline to complement development of C21 in IPF in due course.”

Just now:

Vicore Reports Positive Results for the Pivotal Study of its Digital Therapy for Patients with Pulmonary Fibrosis
The COMPANION pivotal study met the primary endpoint and demonstrated significantly reduced anxiety in patients with pulmonary fibrosis.
AlmeeTM is the first digital therapy to address the psychological symptom burden of living with pulmonary fibrosis.
Stockholm, January 4, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced positive results of the COMPANION study (NCT05330312), investigating the efficacy of AlmeeTM, a 9-week digital cognitive behavioral therapy (CBT) accessed through a smartphone or tablet.

The study met its primary endpoint, change from baseline in GAD-7 anxiety scores, with a statistically significant 2.7-point improvement of anxiety symptoms in the group treated with Almee compared to control, where a change in GAD-7 score of more than 1.8 points is considered clinically meaningful[1]. The GAD-7 scale is widely used in clinical practice as an assessment tool for anxiety; scoring ranges from 0 to 21 with four levels spanning minimal anxiety (0 to 4) to severe (15 to 21). The observed 2.7-point improvement reflects promising efficacy in reducing anxiety levels and offering tangible relief to individuals coping with pulmonary fibrosis (PF). Quality of life, measured by the K-BILD[2], was a key secondary endpoint and improved by 4.4 points compared to control, and the K-BILD psychological domain improved by 6.5 points.

The COMPANION study enrolled 108 participants from across the United States in a randomized, controlled, parallel-group clinical investigation evaluating the impact of Almee on the psychological symptom burden in adults diagnosed with pulmonary fibrosis. Living with a deadly disease for which there is currently no curative treatment available has a negative impact on mental health and quality of life[3]; the aim of Almee is to provide personalized and accessible psychological support for these patients.

“It is very encouraging to see a digital CBT demonstrating a clear clinical benefit for individuals suffering from the mental health burden that accompanies pulmonary fibrosis,” said COMPANION study Principal Investigator Dr. Maureen Horton, Professor of Pulmonary and Critical Care Medicine Johns Hopkins University School of Medicine, retired. "Providing behavior-modifying tools that enhance quality of life represents a new addition to a comprehensive treatment approach for patients living with this devastating disease.”

“We’re so pleased to see these positive results in the COMPANION pivotal study,” said Ahmed Mousa, Chief Executive Officer of Vicore, “and believe that Almee can play a key role in combination with molecular therapies to address the suffering of individuals with pulmonary fibrosis in a holistic way.”

Vicore plans to present full results from the COMPANION study at a conference in 2024. The company will seek to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis, spearheading the continued development of innovation in improved therapy with software-molecular combination therapies.

Almee is subject to medical device regulation in the United States and Europe and is developed in partnership with Alex Therapeutics.

For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437 0235, ahmed.mousa@vicorepharma.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

This information was submitted for publication on January 4, 2024, at 08:00 CET.

About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

About Alex Therapeutics
Alex Therapeutics, a digital health company, partners with pharmaceutical companies to help patients with disease and treatment-specific challenges through clinically validated apps. With its proven, scalable technology platform, as well as expertise in patient-centric design and evidence-based behavior change, Alex Therapeutics treats patients and supports healthcare professionals globally. Alex Therapeutics, alongside its partners, has extensive experience in multi-jurisdiction Software-as-a-Medical-Device (SaMD) regulatory processes, including CE and FDA approval, as well as clinical evidence generation for SaMDs. For more information, visit www.alextherapeutics.com

The new Vicore´s US CEO is working hard to introduce Vicore to the US investors.

new press release from today:

Vicore to Present at Upcoming Investor Conferences

Stockholm, January 31, 2024

Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced that Ahmed Mousa, Chief Executive Officer, will participate in the following investor conferences:

Guggenheim 6th Annual Biotechnology Conference
Location: New York, NY.
Fireside Chat Date and Time: February 7 at 2:30 PM ET/ 8:30 PM CET.
Webcast Registration: Link
Oppenheimer 34th Annual Healthcare Life Sciences Conference
Presentation Date and Time: February 13 at 10:40 AM ET / 4:40 PM CET.
Webcast Registration: Link

Big rubber stamp from Japan. Very positive

Vicore just announced the signing of an exclusive licensing deal with Nippon Shinyaku, to develop the lead candidate C21 in Japan – with initial focus on idiopathic pulmonary fibrosis (IPF). Nippon Shinyaku is a Japanese pharma company with existing expertise in rare respiratory diseases. According to the agreement, Vicore will receive a USD 10m upfront payment and is eligible for USD 275m in additional development and commercial milestones, alongside tiered royalties up to low 20%s based on annual sales of C21 in Japan.

Fin melding, legger inn siste fra Paretosec

Update - 09 Feb 2024
Vicore Pharma Holding AB - Vicore secures exclusive licensing deal for C21 in Japan
Vicore just announced the signing of an exclusive licensing deal with Nippon Shinyaku, to develop the lead candidate C21 in Japan – with initial focus on idiopathic pulmonary fibrosis (IPF). Nippon Shinyaku is a Japanese pharma company with existing expertise in rare respiratory diseases. According to the agreement, Vicore will receive a USD 10m upfront payment and is eligible for USD 275m in additional development and commercial milestones, alongside tiered royalties up to low 20%s based on annual sales of C21 in Japan. We view this as both directly value-adding to Vicore and validating for C21 in IPF, as having an experienced partner in Japan is crucial given the unique regulatory and commercial landscapes in this market – and Japan is often the third biggest market after US and Europe in terms of drug sales. We reiterate our Buy rating on VICO with a 12-month target price of SEK 97.

Detail analysis of today´s announcement by Vicore, including brokers summary

https://fitinvestmentideas.com/2024/02/09/vicore-bioinvent-hofseth-strong-day-for-scandi-pharma/

Vicore Pharma announced signing an out-licensing deal for C21 in Japan.

This is a strong deal that validates the potential for C21 in the IPF indication.

Vicore received USD10m upfront and can receive an additional USD275m in milestones and royalties.

https://fitinvestmentideas.com/2024/02/09/vicore-bioinvent-hofseth-strong-day-for-scandi-pharma/

full press release:

February 09, 2024
Vicore and Nippon Shinyaku Enter into an Exclusive License Agreement to Develop and Commercialize C21 in Japan
C21 is a potentially transformative therapy for the treatment of idiopathic pulmonary fibrosis (IPF)
Vicore to receive USD 10 million upfront and is entitled to up to USD 275 million in milestones in addition to tiered royalty payments
Nippon Shinyaku has been granted exclusive rights to and will be responsible for development of C21 in Japan
Vicore retains rights to develop and commercialize C21 in all markets outside of Japan
Stockholm, February 9, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced it has entered into an exclusive licensing agreement with Nippon Shinyaku Co. Ltd., a leading Japanese pharmaceutical company, to develop and commercialize Vicore’s drug candidate C21 in Japan.

Under the terms of the agreement, Vicore will receive an upfront payment of USD 10 million and is entitled to potential development and commercial milestone payments up to a total of USD 275 million. Vicore is eligible to receive tiered royalties extending into the low 20s based on annual net sales of C21 in Japan. Nippon Shinyaku holds the exclusive right to develop and commercialize C21 in Japan focusing initially on the treatment of idiopathic pulmonary fibrosis (IPF). Nippon Shinyaku will be operationally and financially responsible for development of C21 in Japan and will contribute Japanese patients and sites to the global late-stage development of C21 at its expense. Vicore retains all rights to C21 in the rest of the world.

C21 is an oral therapy being developed for treatment of IPF and has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicines Agency. Although IPF affects approximately 34 000 patients in Japan, treatment options are very limited. In the Phase 2a AIR study, C21 demonstrated transformative potential by safely and effectively stabilizing or improving lung function in previously untreated individuals with IPF. A global Phase 2b ASPIRE study is planned to initiate in the first half of this year.

“This partnership is an important milestone in the development of C21”, said Ahmed Mousa, CEO of Vicore. “Nippon Shinyaku is an ideal partner that brings expertise in rare disease together with a strong track record of successfully partnering with leading companies to bring innovative treatments to the Japanese market. We look forward to working with the Nippon Shinyaku team and leveraging their expertise to successfully develop and commercialize this product in Japan.”

“IPF is a disease with a high unmet medical need,” said Toru Nakai, President & Representative Director of Nippon Shinyaku. “I am delighted to enter into an agreement with Vicore to develop this extremely promising therapy for the Japanese market. C21 will be an important addition to the Nippon Shinyaku portfolio of therapies for rare diseases.”

From Vicore LInkedIn today:

Vicore Pharma ABVicore Pharma AB
2,893 followers2,893 followers
1d • 1d •

Follow
Our CEO, Ahmed Mousa, shared his insights with Citeline’s Scrip on the anticipated Therapeutic Area Advances for 2024 in the latest Scrip Asks segment.

As we prepare to commence our phase 2b ASPIRE trial with C21 for IPF later this year, Ahmed underscores the importance of innovation in the space: “Idiopathic pulmonary fibrosis remains an area of high unmet need with a limited number of programs in clinical development and significant commercial opportunity.”

Read more: https://lnkd.in/eNRMWRb8

Vicore Pharma ABVicore Pharma AB
2,929 followers2,929 followers
1d • 1d •

Vicore Pharma AB is pleased to announce its participation at two investor conferences this Wednesday, March 6th. We invite you to join us as we share the latest updates on our portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (#IPF).

CEO, Ahmed Mousa, will be presenting at the @Cowen Inc. 44th Annual Health Care Conference in Boston, MA, at 12:50 PM ET/6:50 PM CET. Watch the live webcast here: bit.ly/49xDHJt.

Concurrently, Mikael Nygård, VP of Operations and Corporate Strategy, will be presenting at the Carnegie Investment Bank Nordic Healthcare Seminar at 9:00 AM ET/3:00 PM CET.

For full details, please visit: bit.ly/3IeqvgT

Spoke to one of the analyst that cover Vicore:

- the new CEO performs very in with investor's meeting
- meeting a lot of US investors and participates in presentations
- great progress vs the previous CEO
- End of May - the final readout is expected
- 2B study expected to start around that time
- both should be strong catalysts for the stock

I would expect US professional investors to enter VICORE soon. IN my view one of the most interesting Nordic Pharma company.

Vicore Announces FDA Breakthrough Device Designation for AlmeeTM, a Digital Therapy for Patients with Pulmonary Fibrosis
AlmeeTM is the first digital therapy to address anxiety and quality of life in patients living with pulmonary fibrosis (PF).
AlmeeTM has shown effectiveness in reducing anxiety symptoms and improving health-related quality of life in the COMPANION study as reported earlier this year, driving a 2.7-point increase in GAD-7 score and a 4.4 improvement in KBILD score
Stockholm, March 19, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced FDA Breakthrough Device Designation status for AlmeeTM, a 9-week digital cognitive behavioral therapy (CBT), to be used as an adjunct treatment of anxiety symptoms related to PF.

The FDA Breakthrough Devices Program designates those medical devices that are evaluated as providing a more effective treatment for life-threatening or irreversibly debilitating diseases. Breakthrough designation reflects the effectiveness of this new therapy compared to treatment as usual for anxiety associated with pulmonary fibrosis and demonstrates the impactful nature of this digital therapy.

Almee is a patient-facing tool based on CBT principles accessed via a smartphone or tablet. The COMPANION study on Almee demonstrated a 2.7-point improvement over control in GAD-7 (generalized anxiety disorder scale) and a 4.4 improvement in KBILD (King’s Brief Interstitial Lung Disease) total score for quality of life.

PF affects approximately 250,000 people in the United States[1], with increasing incidence[2]. Currently available therapies only slow the progression of this devastating and fatal disease. The physical burden of PF drives psychological impact with studies showing that 60% of patients with PF report having anxiety[3].

“Breakthrough designation sets Almee apart as an innovative and effective tool for PF patients, and it supports our ambition to help patients with pulmonary fibrosis by improving quality of life,” said Ahmed Mousa, Chief Executive Officer of Vicore.

Vicore plans to present Almee and the COMPANION study at a pulmonology conference in 2024.

The company is seeking to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis. “Almee represents the future of healthcare and is poised to deliver significant patient impact as an example of innovation in digital-molecular combination therapies,” said Jessica Shull, PhD, Director of Digital Health at Vicore.

Almee is subject to medical device regulation in the United States and Europe and is developed in partnership with Alex Therapeutics.

For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437 0235, ahmed.mousa@vicorepharma.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

This information was submitted for publication on March 19, 2024, at 08:00 CET.

About AlmeeTM
Almee was developed in collaboration with Alex Therapeutics and is a software built for patients to be used on smartphones or tablets. The application includes psychological exercises based on CBT principles, and other interactive methodologies designed to increase beneficial actions and thoughts and improve anxiety and quality of life.

About the COMPANION trial
The trial was an open randomized study in 110 patients who were not on cognitive behavioral therapy but could be on anxiolytic or anti-depressant therapy or both. Positive topline data in the study was reported in January 2024. The measurements were focused on anxiety using validated instruments like GAD-7, and on quality of life using the K-BILD questionnaire. The study was analyzed using predefined criteria and analysis methods.

About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

About Alex Therapeutics
Alex Therapeutics, a digital health company, partners with pharmaceutical companies to help patients with disease and treatment-specific challenges through clinically validated apps. With its proven, scalable technology platform, as well as expertise in patient-centric design and evidence-based behavior change, Alex Therapeutics treats patients and supports healthcare professionals globally. Alex Therapeutics, alongside its partners, has extensive experience in multi-jurisdiction Software-as-a-Medical-Device (SaMD) regulatory processes, including CE and FDA approval, as well as clinical evidence generation for SaMDs. For more information, visit www.alextherapeutics.com

https://pharmaceuticalmanufacturer.media/pharma-manufacturing-news/latest-pharmaceutical-manufacturing-news/vicore-announces-fda-breakthrough-device-designation-for-alm/

https://pharmaphorum.com/news/vicores-lung-disease-digital-therapy-gets-breakthrough-tag

Vicore published today their annual report

https://storage.mfn.se/8f8566ee-b625-4290-9afc-c8417062ea75/vicore-annual-report-2023.pdf

CEO comments from today´s published annual report:


comments
I am pleased to have the opportunity to
reflect on the significant achievements
and strategic milestones that Vicore
has attained in 2023 and in the year to
date. It has been an incredibly rewarding
journey since I joined the company in
September 2023. I am grateful for the
support of the Vicore team, clinician
community, IPF patients and patient
groups, as well as our investors and
shareholders, whose dedication to
having a meaningful impact on this
devastating disease continue to drive
our success.
With recruitment of the phase 2a
study (AIR) with C21 in IPF successfully
completed, we eagerly anticipate the
publication of the final results in the first
half of this year. The promising interim
results, last presented in May, showed a
stabilization and a subsequent improvement in lung function as measured by
FVC (Forced Vital Capacity) over 36
weeks, demonstrate the disease-modifying transformative potential of C21
and give us confidence for a continued
positive outcome.
Looking ahead, we are excited to
embark on the next phase of our journey
with the initiation of the Phase 2b
ASPIRE study. This study represents
a critical step forward in advancing
the development of C21 and bringing
us closer to offering a transformative
treatment option for IPF patients
worldwide.
We successfully strengthened our
patent portfolio in the summer with the
approval of an enteric coating formulation of C21 in the United States and
Europe. The formulation improves the
uptake of C21 and the patent protects
all forms of enteric coatings of C21 up
until at least year 2041.
In the year to date, we achieved two
further milestones reflecting our ability
to put in place and execute a strategy to
drive value for our stakeholders.
First, we reported positive results
from the pivotal study of Almee™, our
digital therapeutic, designed to address
anxiety in pulmonary fibrosis patients.
This study, COMPANION, demonstrated
a statistically significant improvement
With recruitment of the AIR study successfully completed, we eagerly anticipate the
publication of final results in the first half of this year.
Looking ahead, we are excited to embark on the next phase of our journey with the initiation of the Phase 2b ASPIRE study. This study represents a critical step forward in
advancing the development of C21 and bringing us closer to offering a transformative
treatment option for IPF patients worldwide.
√
8 | Annual report 2023 Vicore Pharma Holding AB (publ)
but also reinforces our commitment
to expanding the global reach of C21
and delivering innovative treatments to
patients worldwide.
In line with our commitment to prioritizing our research and development
efforts, we made the strategic decision
to discontinue our preclinical IMiD program. This strategic realignment allows
us to focus our resources on advancing
C21, maximizing our impact in addressing the unmet needs of patients with
IPF. In addition to advancement of our
current priorities, our strategic review of
the early-stage molecules and potential
additional indications where we believe
AT2 agonism can play a meaningful role
is ongoing.
in anxiety symptoms, underscoring our
commitment to improving the holistic
well-being of patients affected by
respiratory diseases. In addition, In addition, Vicore received FDA breakthrough
device designation status for AlmeeTM.
The FDA's breakthrough device program
covers medical devices that are deemed
to offer a more effective treatment for
life-threatening or irreversibly debilitating diseases and sets AlmeeTM apart as
an innovative and effective tool for PF
patients.
And second, we entered into partnership with Nippon Shinyaku Co. Ltd. for
the development and commercialization
of C21 in Japan. This partnership not
only strengthens our financial position,
I want to extend my sincere appreciation to our shareholders, employees,
and partners for their continued support
and dedication. Together, we are poised
to achieve even greater success in the
pursuit of our mission to improve the
lives of patients worldwide.
Ahmed Mousa

The new US-based Vicore´s CEO is trying hard to introduce VIcore to US based investors. Latest news from today:

Vicore Announces Presentations at the 2024 American Thoracic Society International Conference
Sessions at ATS to include an oral late-breaking presentation of the final results from the Phase 2a AIR trial of buloxibutid (C21) in IPF
Additional presentations include preclinical and translational data reflecting the potency of buloxibutid’s upstream mechanism of action as well as the design of the upcoming Phase 2b ASPIRE trial
Vicore also to be featured in a poster presentation at the ATS Respiratory Innovation Summit
Stockholm, March 28, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced multiple presentations at the 2024 American Thoracic Society (ATS) International Conference, including an oral late-breaking presentation of the final Phase 2a AIR data of buloxibutid in patients suffering from idiopathic pulmonary fibrosis (IPF).

“We are pleased to showcase a series of presentations at the upcoming ATS International Conference,” said Ahmed Mousa, Chief Executive Officer of Vicore Pharma. “In addition to the final Phase 2a AIR data, these presentations will highlight the power of our upstream tissue repair mechanism and provide further details on our planned Phase 2b ASPIRE trial of buloxibutid in IPF.”

“In the previously disclosed interim results of the Phase 2a AIR trial, buloxibutid demonstrated the ability to stabilize and subsequently improve lung function as measured by forced vital capacity, in individuals with the life-shortening disease, idiopathic pulmonary fibrosis” said Toby Maher, MD, Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California. “I’m very much looking forward to presenting the final data at the ATS conference in May which will include all patients treated for up to 36 weeks with this promising therapy.”

Vicore’s abstracts for the conference are available on the ATS’s 2024 online program:

Oral, Late-Breaking Presentation
Mini Symposium A18: Fixing What’s Broken: Novel Therapeutics for Lung Remodeling
Date: Sunday May 19, 2024
Presentation Time: 10:39 AM PT
Location: San Diego Convention Center, Room 8
Abstract: Buloxibutid, a Novel Angiotensin II Type 2 Receptor Agonist, Stabilized and Improved Lung Function in Individuals with Idiopathic Pulmonary Fibrosis in the 36-week Phase 2 AIR Trial

Poster Presentation
Poster Discussion Session B30: Scarred for Life: Translational Research in Interstitial Abnormalities and Lung Fibrosis
Date: Monday May 20, 2024
Presentation Time: 9:15 AM PT
Location: San Diego Convention Center, Room 31A-C
Abstract: Deciphering the Clinical Efficacy Mechanisms of Buloxibutid in Idiopathic Pulmonary Fibrosis

Poster Presentation
Thematic Poster Session B48: New Treatments in Diffuse Parenchymal Lung Disease
Date: Monday May 20, 2024
Presentation Time: 11:30 AM PT
Location: San Diego Convention Center, TDP07
Abstract: Crafting a Patient-focused Phase 2b Trial (ASPIRE) to Evaluate Efficacy and Safety of Buloxibutid in Individuals with Idiopathic Pulmonary Fibrosis (IPF)

In addition to these presentations, Vicore will be featured as a poster presented at the ATS 2024 Respiratory Innovation Summit, a meeting attracting representatives from pharma business development, venture capital, government, academia, and clinical medicine, on May 17, 2024. The poster will outline the current understanding of the role of angiotensin II type 2 receptor agonism in IPF and the clinical development program for buloxibutid.

For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437 0235, ahmed.mousa@vicorepharma.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

This information was submitted for publication on March 28, 2024, at 08:00 CET.

About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). Buloxibutid (C21) is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Almee has received Breakthrough Device Designation from the FDA, reflecting its potential to have transformative impact. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

About the AIR trial
AIR is a single arm Phase 2a trial of buloxibutid in idiopathic pulmonary fibrosis (IPF). The trial includes centrally read high resolution computerized tomography (HRCT) to establish the diagnosis of IPF and spirometry in line with American Thoracic Society (ATS) protocols to measure forced vital capacity (FVC), the regulatory endpoint central to approval of therapeutics in IPF. In a previously reported interim analysis, patients on buloxibutid showed stabilization and subsequently improvement in lung function as measured by FVC over the 36 week dosing period.

Vicore today announced they will present the final readout of their 2a study at the most important annual conference for the IPF diseases. One would guess, that they would not choose this venue, if they would not believe the data are extremely good. The data has been extremely good in every past readout.

“We are pleased to showcase a series of presentations at the upcoming ATS International Conference,” said Ahmed Mousa, Chief Executive Officer of Vicore Pharma. “In addition to the final Phase 2a AIR data, these presentations will highlight the power of our upstream tissue repair mechanism and provide further details on our planned Phase 2b ASPIRE trial of buloxibutid in IPF.”

“In the previously disclosed interim results of the Phase 2a AIR trial, buloxibutid demonstrated the ability to stabilize and subsequently improve lung function as measured by forced vital capacity, in individuals with the life-shortening disease, idiopathic pulmonary fibrosis” said Toby Maher, MD, Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California. “I’m very much looking forward to presenting the final data at the ATS conference in May which will include all patients treated for up to 36 weeks with this promising therapy.”

Noen som vet noe?
Voldsomt fart på denne i dag, men finner ingen ingen nyheter..

Vicore up 36% in April.

the new US based CEO of Vicore is starting to succeed in bringing in US investors. THe company is due to present its results of their 2A study in the biggest annual conference for the IPF. If the results were bad, they would not present it in the most important venue. Investors are warming up to the story. See the link for the full investment write up.

Vicore Pharma post on LInkedin:

Our CEO, Ahmed Mousa, was recently featured on the Drug Discovery World 'In Conversation With' podcast, where he discussed Vicore Pharma AB ATRAG formulations for rare lung diseases. Listen to the episode here as we explore the potential of this new class of drug candidates: bit.ly/4cb1hh2

https://www.ddw-online.com/new-podcast-exploring-the-potential-of-a-new-class-of-drug-candidates-28890-202403/

Vicore actively talking to investors: todays announcement

Stockholm, April 12, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced participation in the following investor conferences:

Kempen Life Sciences Conference
Location: Amsterdam, Holland
Date: April 16
Company Participants: Hans Jeppsson, CFO, and Bertil Lindmark, CMO

Aktiespararna - Digital Temadag - Life Science
Location: Virtual
Presenter: Mikael Nygård, VP Operations and Corporate Strategy
Presentation Date and Time: April 17 at 9:20 AM ET/3:20 PM CET
Webcast: https://www.aktiespararna.se/aktiviteter/digital-temadag---life-science-47005

You can watch Vicore presentation online today:

Linkedin
Vicore Pharma AB
49m • 49m •

We are pleased to announce that Mikael Nygård, VP Operations and Corporate Strategy, will present recent and upcoming activities at Aktiespararnas digital life science event today. Register to the event in the link below and tune in at 15:20 CET:

https://lnkd.in/g_7YRn9J

Vicore idea is playing out, still early innings

Stock is up 27% in April at 20 SEK vs PAreto Price Target of SEK 97

On May 16-22 there is the biggest IPF conference in the US. Vicore has chosen to present their final readout of their 2a study. If the readout would not be positive, Vicore would not have chosen to present it at the biggest event for the industry. That is what is behind the big move in April.

Vicore has the best ever results in IPF. Drugs with much worse results have sold for 4 billion USD in 2020s.

Pareto calls Vicore multibillion dollar company in the making. We are buyers.

Legger inn siste oppdatering fra Pareto etter presentasjonen i går.

Update - 22 May 2024
Vicore Pharma Holding AB - Further details from the webcast on C21’s phase 2a IPF data
Vicore today held a webcast going through details of the phase 2a data of C21 in IPF. Besides the additional details discussed in our previous newsflash, VICO showed a detailed graph highlighting how each subgroup on average saw their lung function increase over the 36 weeks period with a trajectory pointing upwards over time – correlating time trends also for the biomarkers. Key opinion leader (KOL) Toby Maher, who presents most IPF data sets, including from VICO’s competitors, stressed the robustness of the data by highlighting that the measurements were conducted as for registrational trials and how such a profile is not seen by other approaches. With VICO’s robust and de-risked IPF dataset, we note that the non-risk adjusted, fully diluted upside in our valuation is SEK 372 – which still falls well below to what Roche paid for its marketed drug (USD 8.3 bn acquisition of InterMune in 2014). We reiterate our Buy rating on VICO with a target price of SEK 97.

Calliditas is up 88% today - after being acquired by the Japanese.

Vicore and Bioinvent next takeover candidates?