Forum's encenicline placed on clinical hold

Forum Pharmaceuticals Inc. (Waltham, Mass.) said FDA placed a clinical hold on all trials of encenicline ( EVP-6124) to treat Alzheimer's disease after a "very small number" of serious gastrointestinal-related safety events were observed in AD studies. The company declined to disclose the number and types of GI events.

FDA also placed a clinical hold on a long-term extension trial of encenicline to treat cognitive impairment in schizophrenia. Two ongoing Phase III trials of encenicline in the indication will continue and investigators will monitor GI safety. Data are expected in 1H16. The company said there have been no reports of similar serious GI-related events in the trials for cognitive impairment in schizophrenia. ...