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I den ferske presentasjonen deres vises det til dette som bakgrunn for at BerGenBio’s bemcentinib har blitt utvalgt som første kandidat til et (ultra) fast-track løp til potensiell behandling av COVID-19:

• Preclinical data suggest that bemcentinib is potentially useful for the treatment of early SARS-CoV-2 infection, as it selectively inhibits AXL kinase activity
• Bemcentinib selected as the first candidate to be fast-tracked in a new UK national multi-centre randomised Phase II clinical trial initiative to investigate potential treatments for hospitalised COVID-19 patients
• ACCORD (ACcelerating COVID-19 Research & Development platform) study is funded by the UK Department of Health and Social Care and UK Research and Innovation
• Study is a collaboration between the UK Government Scientific Office, the NIHR’s Biomedical Research centres and clinical research company IQVIA
• Professor Tom Wilkinson is the academic lead of ACCORD-2, based at the National Institute for Health Research (NIHR) Southampton Biomedical Research Centre
• The study will test 120 patients across 6 UK NHS hospital trusts, with the first patients due to be treated imminently

Her er det selskapet er i gang med:

Protocol title:
A Multicentre, Seamless, Phase 2 Adaptive Randomisation Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients

Rationale:
There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19 disease, and there is an urgent public health need for rapid development of such interventions.
This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. Candidate drugs that are initially assessed as being efficacious will be moved from an evaluation (pilot) stage to a confirmatory stage, with candidate agents being added to and removed from the study on an ongoing basis, depending on the results of their evaluation. Patients to be included in the study will be hospitalised and may require either supplemental oxygen, noninvasive ventilation or high flow oxygen devices, or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Objectives:
Stage 1: To evaluate the efficacy of candidate agents as add-on therapies tostandard of care (SoC) in patients hospitalised with COVID-19 in a screening stage.
Stage 2: To confirm the efficacy of identified efficacious candidate agents in patients hospitalised with COVID-19 in an expansion stage.

Vurderingsgrunnlaget er rigget slik:

Endpoints:
• Time to clinical improvement of at least 2 points (from randomisation) of patients stage 3, 4 or 5 on a 9-point category ordinal scale, or live discharge from the hospital, whichever comes first (this will also define the “responder” for the response rate analyses).

9-Point Category Ordinal Scale:
0. Uninfected, no clinical or virological evidence of infection
1. Ambulatory, no limitation of activities
2. Ambulatory, limitation of activities
3. Hospitalised – mild disease, no oxygen therapy
4. Hospitalised – mild disease, oxygen by mask or nasal prongs
5. Hospitalised – severe disease, noninvasive ventilation or high flow oxygen
6. Hospitalised – severe disease, intubation and mechanical ventilation
7. Hospitalised – severe disease, ventilation and additional organ support – pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)
8. Death

Prosessen oppsummert + stegene videre:

Summary & next steps
• Mechanistic and preclinical research supports rationale to treat COVID-19 with selective AXL inhibition
• ACCORD study aims to get an early indication of whether potential drug candidates could save the lives and improve the outcomes of the most vulnerable patients with COVID-19
• Top line data from the Phase II study will readout within a few months
• If results are positive, bemcentinib will advance rapidly into the large-scale Phase III trials currently in progress across the UK
• If successful, bemcentinib would ease pressures on hospital intensive care units, and ultimately treat thousands of patients
• We will provide timely updates on trial progress

Hele presentasjonen ligger her:
https://www.bergenbio.com/wp-content/uploads/2020/04/COVID-19-Webcast-presentation-29-April-2020.pdf

Håper dette er nyttig, samt viser at det allerede ligger konkrete funn bak å bli førstekandidat i denne prosessen.