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On the 13th of May 2021, Dr Missling had conference call on the Q1 2021 results. The call was very brief but the questions from analysts were more detailed and aimed at elucidating future prospects of the company.
One was of interest to me over immediate promises. Namely, question about dropout rate in Phase2a Alzheimer’s study over the 5 years.
I have written about the dementia epdemiology and the dropout rate among Alzheimer’s patients in particular. link: https://piotrpeterblog.com/2021/04/11/the-ideal-dementia-drug-and-dementia-patients-population/ , link: https://piotrpeterblog.com/2021/03/20/can-blarcamesine-rescue-those-above-mmse-20-with-alzheimers-avxl-blarcamesine/ .
The Eligibility Criteria called for adults between 55 years and 85 years. This range covers Alzheimer’s of 85 years old patient to statistically last only 2 years to live to be cut short by comorbidity, and 55 years old otherwise healthy succumbing to Alzheimer’s dementia for the next 10 years till he dies of it. Sample with 32 patients is very sensitive to these varations so the data can be taken to be interpreted both ways. later we see that a suprising picture is emerging.
I have normalized the results of over 400 subjects study of natural run of the disease to 32 patient sample size. All this was done was to compare the amout of dropout in Phase2a Alzheimer’s and the reference link: https://pubmed.ncbi.nlm.nih.gov/10404988/ . I included the possible outcomes of 10, 15 and 21 patients left in the OLE and the Humanitarian Examption all counting on 5 years.
It is very hard to say anything specific here. We are not privy to the detailed data on all the patients. Dr. Missling has revealed that the drug works best on people who have not deteriorated below 20 MMSE points. 6 patients intially responded strongly to the drug. Later 4 responded strongly with 2 deteriorating much slower. Most of the death with dementia are due to comorbidity. Statistically, raw dropout rate give us an indication that Blarcamesine is doing better than “natural” progression of the disease but the situation is so complex that nothig can be said with any certainty. But then again, let’s look at the first year (57 weeks data for MMSE scores) results.
I made the calculations for three separate groups of patients. What is initialy visible is that;
- 4 patients with average MMSE score = 23 increased score by 3.5 points with narrow SD +/-0.7
- 4 patients with possible average MMSE score = 19 deteriorate -4.1 MMSE points/y the rate of 184% of ADNI model and wide SD of +/-3.2
- 15 patients detriorated even faster -5.3 +/-2.4 MMSE points/y 240% of ADNI rate -2.2 MMSE points/y. Yet the dispersion is smaller than in case of patients in point 2.
Let’s put in equaly importan piece of information. The APOE e4 gene distribution.
What puzzles me is that most of the patients are deteriorating double the rate ADNI synthetic placebo. If this continues then soon may be that many of these patients will die with very low MMSE scores. Either the large portion of Phase2a subjects were very old or deteriorated rapidly double the rate of ADNI synthetic placebo. In period of 5 years this can make a big difference. Taking into consideration APOE e4 distribution, and the double rate even the low number of 10 patients remaining after 5 years is Big Big Number.
There has been other statement from Dr. Missling who said that over time even those who do not initially respond to Blarcamesine start responding over longer time frame. The first year brings very high number of dropouts as if the population would be “very sick” then next 2 years the dropouts beat the normalized curve on slope first than on absolute number of patients still in program. This result holds for the next 2 years to total of 5 years.
My take on the Conference Call. People are concenrned about the data, but not the data itself but the timely data release. The data release might be done allright, but the research organization might drag its feet. Dr. Missling might have been very optimistic and enthusiastic over the data but the research organization might be not be keeping its inintial deadline.
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