The FDA has granted Fast Track designation to encenicline, FORUM Pharmaceuticals’ lead compound in development to treat cognitive impairment in schizophrenia. Encenicline is a novel alpha 7 agonist in phase III development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer's disease. The company recently completed patient enrollment in its pivotal phase III COGNITIV SZ clinical trial program investigating the use of encenicline as a pro-cognitive therapy in patients with schizophrenia who are currently being treated with atypical antipsychotics.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and to demonstrate the potential to address unmet medical needs.
Deborah Dunsire, M.D., president and CEO of FORUM Pharmaceuticals, said, "Cognitive impairment is a debilitating condition that can severely impact patients' ability to function effectively in activities of daily living, such as the ability to live independently, to work or attend school, to have relationships and to participate in social interactions and the community. Nearly all patients with schizophrenia are affected with cognitive impairment and no therapy currently is available.
"FORUM's ongoing phase III COGNITIV SZ clinical trial program recently completed recruitment of more than 1,500 patients, and we expect to announce top-line results from those trials in the first half of 2016," continued Dunsire. "Encenicline also is being investigated to treat Alzheimer's disease, and patient enrollment is well underway in our ongoing multinational phase III COGNITIV AD clinical trial program."