Forum Pharmaceuticals announced topline results from two Phase 3 clinical trials evaluating encenicline (FRM-6124) in patients with cognitive impairment in schizophrenia (CIS).
The Phase 3 clinical program for encenicline in CIS includes 2 parallel, randomized, double-blind, placebo-controlled studies (015 and 016) evaluating the efficacy and safety of 2 doses of once daily oral encenicline vs. placebo as a pro-cognitive treatment in 750 patients with schizophrenia when added to atypical antipsychotic therapy. The co-primary endpoints were the effects on cognitive function as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Neurocognitive Composite Score, and on patient function as measured by the interview-based Schizophrenia Cognition Rating Scale (SCoRS).
Results demonstrated that both studies failed to meet their co-primary endpoints based on effects on cognitive function and patient function. In addition, an unexpectedly high placebo response was also observed in both trials. However, the studies showed that encenicline demonstrated a favorable safety and tolerability profile. The Company expects to further analyze the study data and present detailed results at a future scientific meeting.
Encenicline is a novel, highly brain-penetrant, selective, and potent agonist of the alpha 7 receptor found on hippocampal and cortical neurons involved in cognition.
For more information visit Forumpharma.com.