Cassava Sciences Inc. SAVA inventory plunged Monday after the corporate launched topline knowledge from the Section 3 ReThink-ALZ examine of simufilam in mild-to-moderate Alzheimer’s illness.
The trial didn’t meet the pre-specified co-primary, secondary, and exploratory biomarker endpoints.
In July, CEO Rick Barry wrote a letter to shareholders and staff, saying that the corporate is within the remaining levels of testing simufilam and has important monetary and emotional stakes.
The co-primary endpoints had been the change in cognition and performance from baseline to the top of the double-blind remedy interval at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, evaluating simufilam to placebo.
Simufilam continued to show an general favorable security profile.
“The outcomes are disappointing…We took cautious measures to enroll sufferers with mild-to-moderate AD. Regardless of that, the lack of cognition within the placebo group was much less pronounced than was beforehand reported in different placebo-controlled research in AD…” stated Rick Barry, President and Chief Govt Officer.
The corporate stated the failed trial outcomes have impacted its second Section 3 trial, ReFocus-ALZ, and determined to discontinue ReFocus-ALZ. The corporate can even be discontinuing the Open Label Extension examine.
The whole 52-week dataset can be obtainable from the examine together with a big portion of 76-week knowledge.
Cassava will proceed to evaluation the info and consider the subsequent steps. We plan to share the detailed outcomes at a future medical assembly.
Cassava has been within the headlines for fabricating knowledge from simufilam drug trials.
In September, Cassava Sciences agreed to pay over $40 million to resolve SEC costs over deceptive statements associated to a Section 2 trial of the corporate’s controversial Alzheimer’s drug, simufilam.
The SEC additionally charged Hoau-Yan Wang, a guide and co-developer of the drug, with manipulating trial outcomes.
The SEC’s investigation discovered that in September 2020, Cassava disclosed manipulated knowledge from the trial, which falsely advised dramatic enhancements in Alzheimer’s biomarkers like complete tau and phosphorylated tau.
Value Motion: SAVA inventory is down 84.2% at $4.19 throughout the premarket session finally test Monday.
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