Cognition Therapeutics met with the FDA to discuss Phase 2 trial results for their Alzheimer’s drug, zervimesine (CT1812), and outline plans for a Phase 3 trial. The company believes the meeting established a viable path towards submitting a new drug application. The FDA’s formal meeting minutes, expected in August, will confirm the regulatory strategy.
This development is potentially crucial for Alzheimer’s patients as zervimesine offers a novel approach to treating the disease by targeting the sigma-2 receptor. This differs from existing therapies and could represent a significant advancement in treatment options, particularly if the Phase 3 trial confirms the positive safety and tolerability profile observed in earlier studies. A successful Phase 3 trial could offer renewed hope for a disease with limited effective treatments.
The Phase 2 SHINE study, funded by a $30 million NIH grant, involved 153 mild-to-moderate Alzheimer’s patients and achieved its primary endpoints of safety and tolerability. The study also assessed changes in cognition and function. Participants received either a placebo or one of two zervimesine doses (100mg or 300mg) daily for six months. Zervimesine, an oral medication taken once daily, aims to interrupt the toxic effects of proteins associated with Alzheimer’s, potentially slowing disease progression.
The outcome of the FDA’s formal minutes will significantly influence Cognition Therapeutics’ next steps. Confirmation of a clear regulatory pathway will allow the company to initiate the pivotal Phase 3 trial, bringing zervimesine closer to potential market approval and offering a new therapeutic avenue for Alzheimer’s patients. This news also positively impacts the broader Alzheimer’s landscape by highlighting continued research and development efforts in this critical area. The progress of zervimesine will be closely watched by researchers, investors, and the patient community.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
