Overblown Stock Market Reaction to Simufilam results

The stock market reaction to Simufilam’s 1 year open label results is extremely overblown.  Here is a link to the results — https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-announces-positive-top-line-clinical-results

First: no other therapy has shown improvement in Alzheimer patients.  The best they can claim is a slower rate of decline.

Second: In 30+ years of clinical neurologic practice, I never saw anyone with Alzheimer’s get better after a year. One or two remained stable for a year, but everyone else got worse. Cassava’s results are impressive (with nearly half improving at one year)  and unique. There is little reason to doubt them, given the way the data has been handled.

Third: even though not a controlled study, a placebo effect is extremely unlikely given my clinical experience with Cognex (Tacrine) when it came out — for details please see — https://luysii.wordpress.com/2023/01/25/why-cassavas-simufilam-results-are-not-a-placebo-effect/

Fourth: the realities of clinical practice.  Assuming that Simufilam is released with data similar to the 1 year results, as a physician I would be remiss if I didn’t offer a drug with nearly a 50% chance of improvement at one year, given the current miserable therapeutic landscape.  Back in the day no patient refused trying Cognex.  Then there is the likelihood of being sued for NOT giving Simufilam, as people were sued for not giving tissue plasminogen activator for stroke, a therapy with minimal evidence for it when it came out — for details please see — https://luysii.wordpress.com/2015/09/02/reproducibility-and-its-discontents/

Fifth: the fact that not everyone responds to Simufilam is irrelevant to eventual FDA approval.  Given all the illnesses we are heir to, even the best drug for any particular illness among the many does not work for everyone with it.  For more on these thoughts please see – https://luysii.wordpress.com/2023/01/26/the-fact-that-not-everyone-responds-to-simufilam-is-irrelevant-to-its-eventual-fda-approval/

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  • GoSAVA  On February 1, 2023 at 12:49 pm

    Thank you very much for giving your own clinic experience to explain the 1 year OL Data. I’ve read your articles for more than a year, and learned a lot from you. Thank you again, Dr Robinson. Taking care of yourself! Happy New Year!

  • mnachtrab  On February 3, 2023 at 10:45 pm

    In mild AD studies about 25-35% of patients actually test better at a year on the ADAS-COG test. I believe that is very unlikely a perfect test that could compare to what you see as a neurologist.

    The families of patients report a broader improvement of general ability to function more normal without supervision. The co-primary endpoint for phase 3 is Change from baseline in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL). I haven’t studied this endpoint extensively but is likely closer to what you witness as a doctor


    • mnachtrab  On February 3, 2023 at 10:59 pm

      This comment does not diminish the fact that the full open label adas-cog was significantly better than all early and mild studies and the full results were better than all mild to moderate studies placebos.

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