WALTHAM, Mass.--(BUSINESS WIRE)--FORUM Pharmaceuticals Inc., a biopharmaceutical company singularly focused on the development and delivery of transformative medicines to treat serious brain diseases, today announced that the U.S. Food and Drug Administration (FDA) has removed a partial clinical hold on the Phase 3 encenicline program for cognitive impairment in schizophrenia (CIS). This partial hold applied to a 26 week Phase 3 extension study. The two global Phase 3 efficacy and safety trials evaluating the use of encenicline to treat CIS are nearing completion, with top-line results anticipated in the first half of 2016.
"We are enthusiastic about the FDA's decision to lift the partial clinical hold on the encenicline CIS program because it enables us to continue to move the schizophrenia program forward," said Deborah Dunsire, M.D., President and Chief Executive Officer of FORUM. "If supported by Phase 3 trial results, we would plan to submit a New Drug Application (NDA) for approval by the FDA. There are no therapies currently available to treat CIS and we believe that encenicline has the potential to benefit patients and families affected by this condition."
Phase 3 trials of encenicline to treat Alzheimer's disease remain on clinical hold while FORUM gathers and analyzes trial data, which will be discussed with the FDA during 2016, to potentially lift the hold and define a possible path forward for encenicline in Alzheimer's disease.
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.
Encenicline is the first alpha 7 agonist drug candidate to reach pivotal Phase 3 development. Two Phase 3 registration multi-center clinical trials (COGNITIV SZ) investigating the use of encenicline for cognitive impairment in schizophrenia have recently completed enrollment (www.clinicaltrials.gov registration numbers NCT01714661 and NCT01716975). Encenicline for the treatment of cognitive impairment in schizophrenia has received Fast Track designation by the U.S. Food and Drug Administration (FDA).
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.
Schizophrenia is a psychiatric disorder that affects approximately 2.2 million Americans, or about one percent of the adult population worldwide, and is usually diagnosed between 15 and 35 years of age. Symptoms of schizophrenia typically include positive and negative symptoms and cognitive impairment. "Positive" symptoms include hallucinations, delusions and paranoia. "Negative" symptoms include loss of motivation and interest in everyday activities, blunting of emotion, decrease in speech and social withdrawal. Cognitive impairments such as difficulty in attention, memory loss and problems processing information and decision-making are recognized as core disabling symptoms of schizophrenia linked to the functional impairment in this condition. The overall annual cost of schizophrenia in the U.S. is estimated at more than $62 billion, according to a study published in the Journal of Clinical Psychiatry.
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.
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