Encenicline: Clinical trial hold

FDA placed a clinical hold on trials evaluating encenicline from Forum in AD patients and a long-term extension trial in cognitive impairment in schizophrenia (CIS). The hold was placed after a “very small number” of serious gastrointestinal safety events were reported in the AD studies. Forum said it is working with FDA to determine the requirements to lift the clinical hold. Forum is evaluating encenicline in the Phase III COGNITIV AD program, which comprises a pair of double-blind, placebo-controlled, international Phase III trials (see BioCentury, Jan. 27, 2014). The company said there have been no reports of similar serious GI-related events in the trials for CIS. Two ongoing Phase III trials of encenicline in CIS will continue and investigators will monitor GI safety. Data are expected in 1H16. ...