Encenicline: Extension study resumed

FDA lifted a partial clinical hold on a double-blind extension study evaluating 1 and 2 mg oral encenicline once daily for 26 weeks in about 1,000 CIS patients who completed 1 of 2 international Phase III trials (see BioCentury, June 22). FDA placed the hold in September. Forum had said a “very small number” of serious gastrointestinal-related safety events were observed in Alzheimer’s disease studies. A hold remains in place on trials of encenicline to treat AD (see BioCentury, Sept. 21). Forum said there have been no reports of similar serious GI-related events in CIS trials. The agency lifted the hold after Forum submitted safety data from the AD and schizophrenia trials. Data from the pair of Phase III trials are expected next half. ...