The topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints. In light of these results, Cassava decided to discontinue a planned second Phase 3 trial of the drug.
Rick Barry stated, 'The results are disappointing for patients and their families who are living with this disease and physicians who have been looking for novel treatment options.' Despite careful patient enrollment measures, the loss of cognition in the placebo group was less pronounced than in other studies.
The company faced scrutiny after an FDA inspection found questionable data practices by CUNY researcher Hoau-Yan Wang, leading to federal agencies questioning Cassava's methods, which adds to ongoing concerns surrounding credibility.
In September, the SEC settled with Cassava over charges that the company misled investors about the effectiveness of its new drug, marking a sequence of setbacks for the pharmaceutical company.
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