US FDA puts clinical hold on FORUM Pharma's encenicline trials

US drug developer FORUM Pharmaceuticals said yesterday that, during verbal discussions with the US Food and Drug Administration, it was advised that studies investigating the use of encenicline in Alzheimer’s disease (AD) have been placed on clinical hold.

A small number of serious gastrointestinal (GI) safety events reported in the AD studies prompted the clinical hold. FORUM has discontinued all study medication in the AD trials and no new patients will be recruited into the studies until the clinical hold is lifted. FORUM plans to work with the FDA to determine a path forward to lift the clinical hold in the AD trial program.

FORUM, formerly known as EnVivo, was also advised that a long-term extension trial in cognitive impairment in schizophrenia (CIS) has been placed on clinical hold. Two fully enrolled Phase III efficacy trials evaluating the use of encenicline to treat CIS will continue, with additional vigilance around GI safety monitoring of patients. Top-line results from these trials are anticipated in the first half of 2016, the company said.