FORUM Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has removed a partial clinical hold on the Phase 3 encenicline program for cognitive impairment in schizophrenia (CIS). This partial hold applied to a 26 week Phase 3 extension study. The two global Phase 3 efficacy and safety trials evaluating the use of encenicline to treat CIS are nearing completion, with top-line results anticipated in the first half of 2016.
“We are enthusiastic about the FDA’s decision to lift the partial clinical hold on the encenicline CIS program because it enables us to continue to move the schizophrenia program forward,” said Deborah Dunsire, M.D., President and Chief Executive Officer of FORUM. “If supported by Phase 3 trial results, we would plan to submit a New Drug Application (NDA) for approval by the FDA. There are no therapies currently available to treat CIS and we believe that encenicline has the potential to benefit patients and families affected by this condition.”
Phase 3 trials of encenicline to treat Alzheimer’s disease remain on clinical hold while FORUM gathers and analyzes trial data, which will be discussed with the FDA during 2016, to potentially lift the hold and define a possible path forward for encenicline in Alzheimer’s disease.