FORUM Pharmaceuticals has announced topline results from two Phase 3 clinical trials in patients with cognitive impairment in schizophrenia (CIS). While encenicline (FRM-6124) demonstrated a favorable safety and tolerability profile in both studies, neither study met its co-primary endpoints based on effect on cognitive function and patient function.
“These results are not what we might have hoped for on behalf of patients. We wish to thank over 1,500 patients who participated as well as the investigators at more than 200 clinical sites,” said Deborah Dunsire, MD, President and CEO of FORUM.
An unexpectedly high placebo response was observed in both trials. Activity was observed across certain sub-groups and secondary endpoints, and these results are being further analyzed.
FORUM expects to share further data from both studies at a future scientific meeting.
In conjunction with this update and the ongoing data analyses, 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.