Replies to post #417073 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

The screening as far as I can tell was to meet the inclusion/exclusion criteria listed here: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD) and not a Precision Medicine trial selecting patients on biomarkers of response to lecanemab.

From this article Lecanemab in Early Alzheimer’s Disease 3638 potential patients were screened to satisfy the 1900 patient enrollment target on those inclusion/exclusion criteria.

This trial made efforts to enhance global enrollment of a diverse group of participants (20% non-White), including in the United States, where 6.1% and 28.1% of the 3638 screened participants and 4.5% and 22.5% of randomly assigned participants were Black and Hispanic, respectively. The characteristics of the participants at baseline were generally similar in the two trial groups (Table 1). These characteristics were similar to what has been observed in population studies involving persons with early Alzheimer’s disease, although there was an underrepresentation of Black persons in the United States and an overrepresentation of Hispanic persons in the United States. The representativeness of the trial population is shown in Table S1 in the Supplementary Appendix.

[georgejjl]

The truth regarding lecanemab trial screening

... Only at step 5 did participants undergo amyloid and tau PET and/or lumbar puncture. Despite the extensive prescreening, 29 percent of screen fails happened here, mostly due to negative amyloid tests. Overall, 5,972 people needed to be screened to obtain 1,795 participants, a 70 percent overall fail rate....

https://www.alzforum.org/news/conference-coverage/lecanemab-sweeps-toxic-av-protofibrils-catches-eyes-trialists

GOD bless,

[WilliamMunny]

Gute Frage, Josef! I asked Herr Doktor Missling that very question at the ASM. He said that apparently there was no such screening limit for whom the drug was approved, at least so far. As I recall he added a bit of a quizzical comment thereafter. He seemed rather animated when I followed up with this question after he commented on his observation that the mabs were only relevant to 20% of the AD market (of 6.5 million, as I remember). I think this issue will be brought up when Anavex goes to the FDA for approval.