Phase 2 Study Results of Novel Investigational Agent for the Treatment of Schizophrenia Announced by Sunovion

Recently Sunovion Pharmaceuticals Inc. positive results for a pivotal phase-2 study titled SEP 361-201 that evaluated the efficacy and safety or SEP-363856, a novel psychotropic agent for the treatment of patients with schizophrenia.

The study met its primary endpoint of demonstrating that by using SEP-363856 for treatment hospitalized patients with worsening of schizophrenia showed statistically significant and clinically meaningful improvement in their total score of the Positive and Negative Syndrome Scale (PANSS) compared to placebo after four weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001). They also found improvement in all major PANSS subscales (p<0.02). Furthermore, patients treated with this drug showed improvement in their overall severity of illness, which was assessed by the Clinical Global Impression Scale - Severity (CGI-S) (p<0.001).

These results were presented at the 57^th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Hollywood, Fla. There, Shitij Kapur, M.B.B.S, Ph.D., F.R.C.P.C., F.Med.Sci., Dean Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne elaborated on the findings saying, ““For more than 60 years, the treatment of schizophrenia has focused on blocking dopamine receptors. Finding a schizophrenia medication that works outside of a direct action on the dopamine system would be highly desirable, and SEP-363856 may represent such a breakthrough. The results of the Phase 2 trial are consistent in showing improvement in positive and negative symptoms, without the traditional side effects associated with dopamine blockers.”

SEP-363856 has a novel non-D2 mechanism of action, making it unique compared to other marketed antipsychotics. The drug was discovered by Sunovion, in a collaboration with PsychoGenics, using related artificial intelligence algorithms to an approach based on using the in vivo phenotypic . This platform is a mechanism independent approach from PsychoGenics that uses the proprietary bioinformatics to detect the potential a given compound will have for treating psychiatric disorders. It provides a set of challenges to a mouse and extracts data, more than 2000 features in a session. The process is considered unbiased as it compares the behavioral profiles of the mouse tested to those from a proprietary reference database.

SEP-363856’s safety and tolerability were also assessed during the SEP 361-201 study, finding that the discontinuation rate was comparable to placebo (21.7 percent and 20.8 percent, respectively) as well as the rate of discontinuation from adverse events (8.3 percent for SEP-363856 and 6.4 percent for placebo).

“We believe that the results from this study illustrate the promise of the PsychoGenics’ target-agnostic approach using the SmartCube^® platform,” said Chairman of the PsychoGenics Scientific Advisory board Eric Nestler, M.D., Ph.D., Director of the Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai. Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group elaborated on the SEP-363856 collaboration saying, ““As a part of our commitment to developing new treatments for major unmet needs in neuropsychiatry, Sunovion has taken a novel approach to the discovery of new psychotropic agents. We are very pleased that SEP-363856, the most advanced molecule derived from our PsychoGenics collaboration, has shown such strong results for patients with schizophrenia.”

According to Sunovion, SEP-363856 is not the only clinical-stage neuropsychiatry drug in the company’s pipeline as it includes several other compounds discovered using, “PsychoGenics SmartCube^® platform together with other novel systems biology approaches.”