Sunovion and PsychoGenics’ Novel Schizophrenia Drug SEP-363856 Receives FDA Breakthrough Therapy Designation

VCBeat (WeChat ID: vcbeat) has learned that SEP-363856, a novel anti-schizophrenia drug jointly developed by biopharmaceutical companies Sunovion Pharmaceuticals and PsychoGenics, has recently received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).

Sunovion Pharmaceuticals developed SEP-363856 using SmartCube, the artificial intelligence algorithm platform under PsychoGenics. The drug is co-owned by both companies, with Sunovion Pharmaceuticals holding the rights to its development and commercialization.

It is understood that a drug may qualify for FDA Breakthrough Therapy designation if preliminary clinical trials demonstrate significant improvement over existing therapies on one or more clinically meaningful endpoints. According to FDA guidance, investigational new drugs granted Breakthrough Therapy designation are eligible for a range of benefits, including intensive guidance from FDA review staff, involvement of senior management in development, commitment of agency resources, and eligibility for rolling review and priority review.

SEP-363856 is a novel antipsychotic medication. Unlike currently marketed agents in the same class, this drug does not bind to dopamine D2 or serotonin 5-HT2A receptors. Although its mechanism of action remains unclear, studies have confirmed that it exerts therapeutic effects in schizophrenia by activating both serotonin 5-HT2A receptors and TAAR1 (trace amine-associated receptor 1).

In December 2018, Sunovion Pharmaceuticals presented the Phase II clinical trial data of SEP-363856 at the 51st Annual Meeting of the American College of Neuropsychopharmacology (ACNP). The data demonstrated that, over a six-month study period, the drug exhibited favorable safety and tolerability in the treatment of acute schizophrenia. Based on these findings, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the drug.

Schizophrenia is a major public health challenge, affecting approximately 23 million people worldwide and about 2.4 million in the United States. It is a persistent, chronic mental disorder. The most characteristic symptoms of schizophrenia include disorganized and illogical thought processes, along with affective disturbances, volitional and behavioral impairments, delusions, and hallucinations.

Antony Loebel, President and Chief Executive Officer of Sunovion Pharmaceuticals, stated, “Antipsychotic medications for schizophrenia were introduced in the 1950s. However, until now, there has been little significant progress in this field. The FDA’s Breakthrough Therapy Designation for SEP-363856 demonstrates its substantial potential in the treatment of schizophrenia. We are currently conducting further studies to evaluate the clinical efficacy of SEP-363856.”

Sunovion Pharmaceuticals, a biopharmaceutical company founded in 1984 and headquartered in Massachusetts, USA, is dedicated to developing therapeutic solutions for patients with central nervous system disorders, respiratory diseases, and other conditions.

PsychoGenics is a biotechnology company specializing in preclinical drug testing and research services. The company is dedicated to developing novel therapeutics for Huntington’s disease, autism spectrum disorder, schizophrenia, depression, post-traumatic stress disorder (PTSD), Alzheimer’s disease, Parkinson’s disease, epilepsy, and other conditions. Its drug development platforms—SmartCube®, NeuroCube®, and PhenoCube®—are utilized by major pharmaceutical companies to develop new drugs.

(Compiled by Jiao Yanli)