Cassava Sciences (NSDQ:SAVA) announced that its experimental Alzheimer’s drug simufilam was associated with an improved cognition score at 12 months. Specifically, recipients of the drug showed a 3.2 point improvement on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) from baseline to month 12.
Austin, Texas–based Cassava also announced that 68% of study participants demonstrated improved ADAS-Cog scores at 12 months. Among participants with improvement, the average increase in ADAS-Cog score was 6.8 points.
The data came from a pre-planned interim analysis of an open-label study.
“We look forward to the initiation of a randomized, double-blind, placebo-controlled pivotal Phase 3 clinical program with simufilam in people with Alzheimer’s disease,” said Remi Barbier, the company’s CEO, in a statement.
Investors were apparently unimpressed, sending SAVA shares down 1.04% apiece to $52.31. Shares continued to slide after hours.
Simufilam is also the target of a citizen petition filed last month asking the FDA to halt two clinical trials associated with the drug over alleged problems associated with laboratory research on the drug.
The petition describes “grave concerns about the quality and integrity” of lab data associated with the drug Simufilam.
Furthermore, it goes on to add that “Cassava’s presentation of clinical biomarker data from the Phase 2b trials raises questions about the validity of the data.”
In a 2020 SEC document, the company reported that it had identified that an outside lab had performed a questionable initial bioanalysis on cerebrospinal fluid samples from its Phase 2b study. It responded by sending backup cerebrospinal fluid samples to another outside lab for bioanalysis. “All bioanalyses were conducted under blinded conditions to eliminate any possibility of bias,” the company wrote in the document.
The law firm Berman Tabacco also announced that it is investigating potential securities law violations related to the citizen petition.
Filed Under: Neurological Disease, Psychiatric/psychotropic drugs