Cassava Sciences reported that its drug did not notably slow cognitive decline in 1,900 individuals with mild to moderate Alzheimer’s disease. The Austin, Texas-based biotechnology firm declared it would cease its advanced clinical trial for the experimental Alzheimer’s medication, marking the end of a protracted effort for regulatory approval. On Monday, the company revealed that the drug, simufilam, showed no significant effect on cognitive decline in trial participants. Richard J. Barry, the company’s CEO, expressed disappointment for patients, their families, and physicians seeking new treatment options. Many dementia researchers were not surprised by these findings, having previously raised concerns about the trial’s continuation given doubts surrounding the drug’s science. Studies that appeared to support the medication have since been retracted from scientific publications. A consulting researcher involved in some of the drug’s key studies was indicted for fraud by a federal grand jury for reportedly falsifying data to secure research funding. In September, the company reached a settlement with the Securities and Exchange Commission regarding claims that Cassava had provided deceptive information about the outcomes of previous clinical trial data. The company did not confirm or refute any wrongdoing. Nevertheless, it continued with its Phase 3 clinical trial, which is usually the final assessment before the FDA decides on the drug’s approval for public use, insisting that there were still studies and clinical findings indicating the drug’s potential value. However, Monday’s results diminished hopes for the drug’s effectiveness, although the company asserted that the trial demonstrated the drug’s safety. Cassava’s future now appears uncertain, as simufilam was its sole drug undergoing clinical trials. After the company’s investor call on Monday morning, Cassava’s stock plummeted by over 80 percent, dealing a significant blow to its devoted investors who had previously valued the company at over $5 billion.
