In an open letter to the Cassava community, President and CEO Rick Barry provided an update on the company's progress, particularly in its clinical trials and regulatory matters.
The rethink phase 3 clinical trial, which enrolled 804 patients at 77 sites, has completed dosing, and top-line results are expected before the end of the year. The trial's primary co-endpoints are the adas-cog12 and adcs-adl scales.
Additionally, the second phase 3 trial, refocus, enrolled 1,125 patients at 78 sites and is expected to release top-line results in mid-2025. This trial includes additional sub-studies, such as measuring cerebrospinal fluid biomarkers and analyzing MRI and PET images.
The company settled with the Securities and Exchange Commission, agreeing to pay a $40 million penalty related to negligent disclosures about its 2020 phase 2b clinical study. Cassava's board of directors conducted a thorough investigation into the allegations and disclosed supplemental information on July 1, 2024.
The phase 2 study, which enrolled 216 patients, showed promising results, with 47 mild patients who took open-label simufilam continuously for 24 months experiencing no mean decline in cognition as measured by adas-cog11. The company emphasized that the phase 3 trials' outcomes may differ from the phase 2 study results.
Barry also addressed concerns about the company's scientific basis, highlighting independent research supporting the biological activity of simufilam conducted by researchers at the Cochin Institute in Paris and Yale University.
As the company approaches critical milestones, Barry expressed his commitment to potentially bringing a much-needed therapy to Alzheimer's patients, underscoring the dedication of the Cassava team to make a difference in the lives of those affected by the disease.
The market has reacted to these announcements by moving the company's shares 2.8% to a price of $26.13. Check out the company's full 8-K submission here.
