Forum Pharmaceuticals said it will restructure its operations—including, apparently, layoffs—following the failure of a pair of Phase III clinical trials for its cognitive impairment in schizophrenia candidate encenicline (FRM-6124).
“The company is implementing a significant restructuring of its organization to appropriately scale its spending and resources and to evaluate a potential path forward, if any,” Forum said in a statement.
That statement summarized negative results from the pair of trials for encenicline, which involved more than 1500 patients, who were evaluated over 26 weeks, as well as investigators at more than 200 clinical sites. Neither study met its co-primary endpoints based on effect on cognitive function and patient function, the company said, although encenicline showed a favorable safety and tolerability profile.
Primary endpoints for the studies were effect on cognitive function as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Neurocognitive Composite Score, and effect on patient function as measured by the interview-based Schizophrenia Cognition Rating Scale (SCoRS).
Forum added that it “expects to share further data from both studies at a future scientific meeting.”
While the privately held company gave no details of its restructuring, the Boston Business Journal reported that the company notified Massachusets’ Division of Career Services of plans to lay off 77 staffers during a 30-day period starting on May 20.
Forum told the state that all 77 employees have been notified and that another 12 staffers could be eliminated “if the company receives adverse clinical trial data,” the newspaper reported.
Encenicline is an agonist of the alpha 7 receptor believed to work in low concentrations to prime the alpha 7 receptor to increase its response to acetylcholine. Forum reasoned that the resulting effect would activate brain networks associated with sensory gating, attention, and cognition, thus enhancing these networks for improved neural processing and improved cognitive performance in areas such as memory and executive function.
Encenicline had also been under study for Alzheimer’s disease (AD), but in September 2015, the FDA placed that program on clinical hold following what the company disclosed as “a small number of serious gastrointestinal (GI) safety events reported in the AD studies.”
The FDA also placed on hold a long-term extension trial in cognitive impairment in schizophrenia, although the two Phase III trials were allowed to proceed with additional GI safety monitoring of patients.
Forum has a license agreement with Mitsubishi Tanabe Pharma for the development and commercialization of encenicline in Japan and several other Asian countries.