Forum Pharmaceuticals announced that the FDA has granted Fast Track designation to encenicline for the treatment of cognitive impairment in schizophrenia.
Forum recently completed patient enrollment for the COGNITIV SZ phase 3 clinical trial program which includes two randomized, double-blind, placebo-controlled studies. The program is evaluating the safety and efficacy of two oral doses of once-daily treatment with encenicline as a pro-cognitive treatment compared to placebo when added to chronic, stable, atypical antipsychotic therapy in people with schizophrenia.
Primary endpoints of the trials include effect on cognitive function and effect on clinical function. The two global 26-week trials enrolled a total of more than 1,500 patients at approximately 200 clinical sites.
Encenicline is an orally administered, selective, and potent agonist of the alpha 7 receptor found in hippocampal and cortical neurons involved in cognition.
In a phase 2 trial, which was sponsored by Forum and results of which were released in March, 319 schizophrenia patients were randomized to receive either encenicline in one of two doses daily, or a placebo, for 12 weeks.
Patients in both encenicline dose groups showed significant cognitive improvement based on various measures, according to a presentation made at the 15th International Congress on Schizophrenia Research. In a subset of 154 patients, the improvement was greater in the higher-dose group (0.9 mg) than the lower-dose cohort (0.27 mg).