Cassava Sciences (NASDAQ: SAVA) plummeted over 83% on Monday following a report that its Alzheimer’s treatment, similar, did not meet the main objectives in Phase 3 trials. The study, known as ReThink-ALZ, looked into the effectiveness of similar in patients diagnosed with mild-to-moderate Alzheimer’s disease for 52 weeks. Compared with a placebo, no significant improvements were observed in cognition or functional abilities.
The trial endpoints included changes in cognitive and functional performance, measured by standard scales such as ADAS-COG12 and ADCS-ADL. Despite the favorable safety profile of simufilam, the results fell short of expectations. According to the CEO Rick Barry, “the placebo group’s cognitive decline was less pronounced than previously observed in similar studies, he said”.
This failure prompted the company to put both of its second Phase 3 trials, ReFocus-ALZ and its Open Label Extension study, on hold. It has announced its intention to publish additional data from the 52-week study, along with partial results from the 76-week dataset, during an upcoming medical meeting.
It is the latest controversy for the company. In September, Cassava Sciences agreed to pay over $40 million to settle SEC charges that it had faked trial data for its similar drug. The SEC also accused a consultant, Hoau-Yan Wang, of manipulating data that overplayed the effectiveness of the drug.
Monday’s results set back years of gains for Cassava, sending its stock to a low of $4.31 per share, its lowest in more than four years. To be sure, the company plans to review its next course of action after this latest failure questions its ultimate prospects in Alzheimer’s drug development.
It is another reminder about how hard it’s proving to be to develop effective drugs against Alzheimer’s. High stakes seem to bring high failure rates.
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