Cassava Sciences Ends Simufilam Development After Phase III Failures

Cassava Sciences has halted all development of simufilam for Alzheimer’s disease after it failed to show benefit in a second Phase III trial (REFOCUS-ALZ, NCT05026177).

Key Findings:

• REFOCUS-ALZ (1,125 patients) failed to meet co-primary, secondary, and biomarker endpoints.
• Co-primary endpoints: Changes in cognition (ADAS-COG12) and function (ADCS-ADL) over 76 weeks.
• Earlier trial (RETHINK-ALZ, NCT04994483) also failed, leading to program termination.
• Simufilam had a favorable safety profile but lacked clinical efficacy.

Financial & Legal Fallout:

• Stock down 92.82% since first Phase III failure.
• November 2024: 85% stock crash following RETHINK-ALZ failure.
• March 25 update: 32% stock drop.
• $40M SEC settlement over alleged misleading Phase IIb trial data.
• Company faced:
• Defamation lawsuit against short sellers
• Citizen petition to FDA to halt trials

Future Plans:

• Shifting focus to other CNS disorders but no specifics yet.
• Unclear financial stability after significant stock value loss.

Cassava’s exit underscores the challenges in Alzheimer’s drug development, with high-profile failures continuing despite industry efforts.

31-03-2025