Final Prognostication Before December 1, 2022 CTAD San Francisco Presentation.

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Refined Illustration For Possible Performance of Blarcamesine On The Background of Donezepil, Simufilam and Donezepil Placebo, All Imperfect Comparison

First thing is to point to a mistaken plus sign of the Avg. Delta ADAS-COG11, which should be -7.21, not 7.21.

• Green Line represents the performance of Donezepil Placebo from Donezepil Label Fig.2. But this is only decline over 24 weeks or 6 months, not 9 months as is the case for Simufilam. For both Blarcamesine (48 weeks or 11 months) and Simufilam (9 months) this would be move farther to the right.
• Red Line represents the performance of Donezepil at 24 weeks of dosing i.e. the apogeum of its performance
• Black Line traces the performance of 50 patients in the Open Label of Simufilam trial, dsed for 9 months.
• Blue Line is a hypothetical performance of Blarcamesine in the high dose cohort (50mg)
• How to read the plot? If you draw horizontal line and this line cuts a curve for given drug, on x-axis is the condition of conginitive perforamnce given cumulative percentage of patients are better off in the trial.
• So Donezepil cut through the X-axis zero line at 82% cumulatine number of patients, which means that 82% patients show improvement with remaing becoming worse off.
• If we draw a line from normal to x-axis we get the same cognitive improvement for all drugs as expressed in the cumulative number patients in the trial being better off.

The question we can have; is the performance curve for Blarcamesine Hig Dose at all plausible?

I have two pieces of information.

On this blog, I posted an interpretation of news piece by $AVXL that claimed average delta MMSE = to about 2 points. The news release claimed that pertained to those who were in the Open Label Extension of Phase2a. If by my skewed logic we assume that this was a way of comunicating progress in high dose cohort of Phase2b/3 and from this plot we calculate the average Delta MMSe to be around 2 to 3 points we are a ball park firgure.

Second thing is that the language change on the Clinicaltrials.com page does not preclude this to be a possibility as the 30mg cohort in phase2a behaved basically as a placebo. It is entirely within realms of possibility that the 30mg cohort is declining even more (Delta MMSE or rather ADAS-COG11) than the 50mg cohort is on average preserving them, all due to ceiling effect against the cognitive healthy. The measured decline ranges from Delta MMSE=-2.2 to even -8.2 points.

We might be on arithmetical decline in overall score for the entire body of the trial, and at the same time much improve just one cohort.

The Judgement Day Cometh on December 1. I am curious,. How far off I am in all my analysis and prognostication?

Meantime, please, take it with grain of salt.