EnVivo Pharmaceuticals starts encenicline Phase 3 study in patients with Alzheimer's disease

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel therapies for central nervous system (CNS) diseases, today announced it has initiated COGNITIV AD, a Phase 3 clinical program evaluating its novel alpha-7 (α7) potentiator, encenicline-hydrochloride (EVP-6124), in patients with Alzheimer's disease (AD). The program is being conducted under a Special Protocol Assessment agreement with the FDA.

"We are pleased to advance encenicline into Phase 3 clinical development in Alzheimer's disease, a significant milestone for our company and promising step forward for patients who desperately need new therapies," said Deborah Dunsire, M.D., president and chief executive officer of EnVivo. "Prior clinical studies of encenicline have demonstrated clinically significant improvements in cognitive function in patients with Alzheimer's disease. For the millions of patients living with AD, we believe encenicline has the potential to make a meaningful difference."

Patient dosing has begun in the 26-week trial, which is designed to evaluate the safety and efficacy of two fixed doses of encenicline compared to placebo in patients with mild to moderate AD who are currently receiving stable treatment with or have been previously treated with an acetylcholinesterase inhibitor.

"There is a profound need for better therapies for the cognitive and functional impairments of Alzheimer's disease," said Lon S. Schneider, M.D., professor of psychiatry and the behavioral sciences, neurology, and gerontology at the University of Southern California (USC); director of the California Alzheimer's Disease Center at USC; clinical core of the NIH-funded USC Alzheimer's Disease Research Center and investigator in the COGNITIV AD Phase 3 clinical program. "Encenicline demonstrated clear, positive effects on cognition in the Phase 2 trial, and we should expect to confirm these outcomes in the large Phase 3 program."