FORUM Pharmaceuticals Inc. operates as a biopharmaceutical company focused on the development and delivery of medicines to treat serious brain diseases that include Alzheimer’s disease, schizophrenia, and frontotemporal dementia. Its products include alpha-7 Receptor Response, an orally administered encenicline; PDE 10 program, an investigational phosphodiesterase inhibitor; and Gamma-secretase modulators to correct the loss-of-function defect in familial Alzheimer’s disease caused by genetic mutations in presenilin proteins. The company also develops genetically targeted therapies, including FRM-0334 for the treatment of the ultra-orphan and frontotemporal dementia. FORUM Pharmaceuticals In...
500 Arsenal Street
Watertown, MA 02472
Founded in 2001
FORUM Pharmaceuticals Inc. Receives U.S. Food and Drug Administration Fast Track Designation for Encenicline to Treat Cognitive Impairment in Schizophrenia
Jun 22 15
FORUM Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to encenicline, FORUM’s lead compound in development to treat cognitive impairment in schizophrenia. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and to demonstrate the potential to address unmet medical needs. Encenicline is a novel alpha 7 agonist in Phase 3 development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer’s disease. The Company recently completed patient enrollment in its pivotal Phase 3 COGNITIV SZ clinical trial program investigating the use of encenicline as a pro-cognitive therapy in patients with schizophrenia who are currently being treated with atypical antipsychotics. The COGNITIV SZ Phase 3 clinical trial program includes two randomized, double-blind, placebo-controlled studies 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 chronic, stable, atypical antipsychotic therapy in people with schizophrenia. Primary endpoints of the trials include effect on cognitive function as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™) Consensus Cognitive Battery (MCCB™), and effect on clinical function as measured by the interview-based Schizophrenia Cognition Rating Scale (SCoRS). Secondary endpoints of the trial include the 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 EuroQoL-5D™ (EQ-5D). Safety will be determined by clinical and laboratory safety assessments. The two global 26-week trials enrolled a total of more than 1,500 patients at approximately 200 clinical sites. Encenicline is a novel, orally administered, highly brain-penetrant, selective, and potent agonist of the alpha 7 receptor found in 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 with sustained effect in schizophrenia and Alzheimer’s disease. 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 not only in Alzheimer’s disease and schizophrenia, but suggest potential in other diseases with cognitive impairment. 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). Additionally, FORUM is investigating the use of encenicline for Alzheimer’s disease through a Special Protocol Assessment with the FDA. Two Phase 3 registration multi-center trials (COGNITIV AD) investigating the use of encenicline for Alzheimer’s disease are ongoing (www.clinicaltrials.gov registration numbers NCT01969123 and NCT01969136). FORUM has a license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of encenicline in Alzheimer’s disease in Japan and several other Asian countries. Schizophrenia is a psychiatric disorder that affects approximately 2.2 million Americans, or about 1% 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.
FORUM Pharmaceuticals Inc. Completes Patient Enrollment in Pivotal Phase 3 Clinical Trial Program of Encenicline for Cognitive Impairment in Schizophrenia
Jun 11 15
FORUM Pharmaceuticals Inc. announced the completion of patient enrollment in its two pivotal Phase 3 clinical trials investigating the use of encenicline to treat cognitive impairment in schizophrenia. The Phase 3 clinical trial program, known as COGNITIV SZ, is designed to assess the safety and efficacy of encenicline compared to placebo as a pro-cognitive therapy in patients with schizophrenia treated with atypical antipsychotics. Each of the two 26-week multinational trials enrolled more than 750 patients. Encenicline is a novel alpha 7 agonist in Phase 3 development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer’s disease.
FORUM Pharmaceuticals Inc. Presents at BIO International Convention 2015, Jun-15-2015 through Jun-18-2015
Jun 10 15
FORUM Pharmaceuticals Inc. Presents at BIO International Convention 2015, Jun-15-2015 through Jun-18-2015. Venue: Pennsylvania Convention Center, Philadelphia, Pennsylvania, United States. Presentation Date & Speakers: Jun-16-2015, Baruch Harris, Senior Director, Corporate Development and Investor Relations, Gerhard Koenig, Chief Scientific Officer and Senior Vice President of Research.