Alzheimer’s Association International conference (AAIC) was held on July 29th – Cassava Sciences presented 9 month cognition data for the first 50 patients enrolled in their open label study. Their slide deck was presented word for word by Dr. Lindsay Burns, SVP and Lead Scientist.
The company used the term encouraging and made no claims of efficacy while describing their results. However, that did not stop many from weighing in. Here are some social media criticisms posted by well known influencers –
An excerpt from the Adam Feuerstein’s article above:
It’s not hard to see past Adam Feuerstein’s implied misogyny and lack of basic research on a publicly available study design. For the record, Dr. Burns, an author of multiple scientific papers, has the following background
Facing criticism for his remarks, Dr. Rob Howard, one of the quoted scientists on the stat+ article, doubled down and posted on his twitter feed.
Dr. Howard ignored the questions surrounding his role in legitimizing the article while only responding to comments from fans and the harassment from reddit trolls. As for comments from users who asked him to take a look at the data and research – crickets.
Their criticism doesn’t change facts. Dr. Burns emphasized this was an open label study and only large phase 3 studies can prove efficacy. How is doing this overblown, uninterpretable or naive? Is being invited to present inappropriate? Before delivering the presentation, cassava had also announced two phase 3 studies.
It’s hard not to question the motives of these personalities and their backers when they engage in rhetoric. Note that their comments were picked up by various media articles to enable the “sell the news” effect that caused the stock to crater ~50%.
Some questions for these social media influencers,
- Are companies that complete open label studies not allowed to present results to academia and investors?
- Is your platform intended to foster progress with constructive criticism or plainly serve as a signal to short sellers and day traders?
- Are you willing to be gracious and admit missteps when wrong?
There exists a world of folks with honorable reputations, who make questionable comments and never leave their echo chambers. They are mostly right but will never admit it when wrong. This blog hopes to critique these positions.
Author’s thesis on 9 month cognition release
The author of this piece acknowledges that Simufilam is not a proven drug. Preclinical studies on mice models and post mortem human brains have illustrated the mechanism of action. Phase 2 trials have shown encouraging results. The ongoing open label study is using a placebo baseline from a meta-analysis of over 20,000 patients with mild to moderate AD. Since a clinical hallmark of Alzheimer’s disease is decline in cognitive function, the improvements shown over 9 months, despite the placebo effect, is unheard of. The small sample size is the biggest concern and any investment should factor that in.
Biomarker results backing cognition were impressive. Here again it must be noted that biomarkers for Alzheimer’s disease is an active subject of research and the correlation between biomarkers and disease progression hasn’t been completely established. Cassava in their studies so far have found decreases in CSF p-tau 181 best correlates with cognition improvement.