Cassava Sciences fights back against allegations disputing trial data

Aug. 25, 2021

Cassava Sciences has responded to harsh allegations — posted overnight — disputing the validity of trial data for its experimental Alzheimer's disease treatment.

The treatment, simufilam, is a proprietary, small molecule oral drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. It is a new approach to treat Alzheimer’s disease.

Yesterday, the Austin, Texas-based biotech announced that it reached an agreement with the FDA under a Special Protocol Assessment (SPA) for its phase 3 studies of oral simufilam for the treatment of Alzheimer's patients. SPA is a process in which sponsors may ask to meet with the FDA to reach an agreement on the design and size of certain clinical trials, clinical studies, or animal studies. 

All was well. But then, overnight, a citizen's petition along with a "whistleblower submission" letter to the FDA was posted on a U.S. government website requesting the FDA halt the current clinical studies of simufilam.

"Cassava Sciences apparently didn't get the Theranos memo" the letter, from former Security and Exchange Commission enforcement  lawyer Jordan Thomas of Labaton Sucharow, starts. It goes on to dispute the validity of clinical biomarker data, the integrity of western blot analyses and the integrity of analyses involving human brain tissue. "The company's own research is riddled with red flags," writes Thomas.

But Cassava Sciences disagrees. The company fired back this morning, with a statement asserting that claims made in the letter regarding scientific integrity are "false and misleading."  Cassava's statement goes point by point, disputing each "fiction" with "fact."