FORUM Pharmaceuticals Inc. Provides Update on Encenicline Phase 3 Clinical Trial Program in Cognitive Impairment in Schizophrenia

WALTHAM, MA, USA I March 24, 2016 I FORUM Pharmaceuticals Inc. today 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.

About the Encenicline Phase 3 Clinical Trial Program in Cognitive Impairment in Schizophrenia (CIS)

The encenicline Phase 3 program in CIS includes two parallel, randomized, double-blind, placebo-controlled studies (015 and 016) evaluating the safety and efficacy of two oral doses of once daily treatment with encenicline as a pro-cognitive treatment compared to placebo when added to atypical antipsychotic therapy in people with schizophrenia. More than 750 patients were evaluated in each study over 26 weeks across 200 sites.

  • Primary Endpoints: 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).
  • Secondary Endpoints: clinical efficacy as measured by the negative subscale of the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression – Severity (CGI-S), Clinical Global Impression – Change Scale (CGI-C), and quality of life, using the EuroQoL5D (EQ-5D).

About Encenicline

Encenicline is a novel, orally administered, highly brain-penetrant, selective, and potent agonist of the alpha 7 receptor found on hippocampal and cortical neurons involved in cognition. Encenicline is believed to work in low concentrations to prime the alpha 7 receptor to increase its response to acetylcholine, a naturally occurring neurotransmitter. This effect is thought to 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 is in development by FORUM Pharmaceuticals as a long-term treatment to improve cognitive function. In preclinical studies, alpha 7 agonists increased neuronal synchronization and enhanced synaptic plasticity, measured by an increase in long-term potentiation (LTP). These effects may be linked to enhanced cognition across different disease states.

FORUM has a license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of encenicline in Japan and several other Asian countries.

About FORUM Pharmaceuticals Inc.

FORUM Pharmaceuticals Inc. (“FORUM Pharmaceuticals” or “FORUM”) is dedicated to developing transformative medicines to restore the minds of people with serious brain disease, empowering them to preserve their identity, dignity and the essence of what makes us human. The Company’s diverse pipeline is focused on discovering and developing new treatments for important neurodegenerative diseases that explore novel mechanisms of action to potentially alter the progression of brain disease and provide improvement in cognitive and overall function. FORUM is privately owned and based in Waltham, Mass. For more information about FORUM, visit www.forumpharma.com.

SOURCE: FORUM Pharmaceuticals

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