Per Redeye idag.

Redeye knew this day was coming. And still, we were caught by some surprise. FDA has granted accelerated approval to aducanumab, the first drug in Alzheimer's that targets the underlying disease pathology. We leave the first note to this news from an Alzinova perspective.

BACKGROUND
Yesterday, in a historic decision, the FDA granted accelerated approval to aduhelm (aducanumab) as the first treatment that targets the underlying disease pathology in Alzheimer’s disease – amyloid beta aggregates in the brain (Aβ). Aβ is the target in Alzinovas vaccine approach in Alzheimer’s. It’s vaccine candidate, ALZ-101, targets the oligomeric forms of Aβ, which is considered to be the real neurotoxic aggregates of Aβ.
In the press release from the FDA, the agency recognizes the complex dataset surrounding aducanumab, which we have followed closely over the years. The agency decided, therefore, to go for the accelerated approval path, in which aduhelm is approved based on its consistency in reducing the level of amyloid plaques in the brain. This is a surrogate endpoint. It means that it is a marker/measure that is thought to predict a clinical benefit but is not in itself a measure of clinical benefit. Under the accelerated approval, Biogen will now have to conduct a phase 4 trial to confirm the anticipated clinical benefit. If unable to do so, the FDA could revoke the drug from the market.
In summary, the FDA has determined that there is substantial evidence that aduhelm reduces amyloid plaque in the brain and that it is reasonably likely to lead to a clinical benefit to patients.

REFLECTIONS
We have followed the aducanumab drama, from the late clinical stage, to the termination of the pivotal trials in March 2019, the resurrection in October 2019, the close regulatory interactions FDA-Biogen during 2019-2020, the unequivocal negative votes from the independent expert panel in November 2020, to the accelerated approval announced yesterday. Still, we were caught by surprise. In our view, the aduhelm benefit/risk profile is, at best, questionable. Having said that, we want to emphasize, once again, that all Aβ molecules stand on their own merits. We have never seen the aduhelm drama as a voting session for or against Aβ as a therapeutic target.

On the back of this complex dataset and the attention around aduhelm, we regard the FDA statement as relatively balanced. Hopefully, this will mark the beginning of an era with increasing investments and research efforts in the neurodegenerative space, ultimately leading to even more efficacious therapies for patients with this devastating disease. We strongly believe that a therapeutic toolbox that leads to combination therapies is what could turn out to be most efficacious. Aβ has a given place in that toolbox, in our view.

THE ALZINOVA PERSPECTIVE
Another factor that was revealed yesterday, and that we will look closer into in our subsequent update in Q3’21 (pending clinical start for ALZ-101), was the pricing for aduhelm. We note a wholesaler acquisition cost (WAC) corresponding to a yearly price of USD 56 thousand at the maintenance dose. Although the WAC is not the net price, this is a higher level than what we expected, especially for aduhelm, considering its questionable benefit/risk profile. The vaccine approach offers a more cost-effective way to battle Alzheimer, as the body itself elicits antibodies towards its target. In our sales model for ALZ-101, we assume a price level around USD 5,500 for the priming shots, and around USD 2,000 for the maintenance shots.

The Alzinova stock closed +40% yesterday. It has opened in positive territory today as well. It both surprises us, and do not. The news yesterday was a regulatory decision on an external drug. No new data was presented. However, we also know that aducanumab news has caused hefty stock reactions in the past.

In terms of Alzinova, we have our eyes on the current timeline for ALZ-101, with anticipated clinical start in Q3’21. It would be a major milestone for Alzinova as a biotech company.

https://www.redeye.se/research/814666/alzinova-historical-external-news?

Oppdatert presentasjon: https://www.alzinova.com/wp-content/uploads/2021/06/2021-06-30-alzinova-company-presentation.pdf