MARLBOROUGH, Mass. & PARAMUS, N.J.—Sunovion Pharmaceuticals Inc. and PsychoGenics Inc. announced today positive results from SEP 361-201at the 57th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Hollywood, Fla. SEP 361-201 is a pivotal Phase 2 study that evaluated the efficacy and safety of SEP-363856, a novel psychotropic agent for the treatment of patients with schizophrenia.
The study met its primary endpoint, demonstrating that hospitalized patients with acute exacerbation of schizophrenia treated with SEP-363856 showed statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo after four weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001). Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale - Severity (CGI-S) (p<0.001). In addition, improvement was found in all major PANSS (positive, negative and general psychopathology) subscales (p<0.02).
“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,” mentioned 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.
“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. The results need to be replicated in further studies and broader populations, but if these results hold, it could be a remarkable advance for patients and health care providers, as well as a great new avenue for exploration of new scientific mechanisms for psychotic disorders.”
SEP-363856 was found to be generally well tolerated with notable similarities to placebo treatment in discontinuation rates; proportion of patients experiencing extrapyramidal symptoms or akathisia; and change in metabolic parameters such as weight, lipids, glucose and prolactin.
SEP-363856 does not bind to D2 or other dopaminergic receptors or to serotonergic receptors (except for 5-HT1A), which are thought to mediate the effects of currently available antipsychotic medicines. Although the exact mechanism of action is unknown, SEP-363856 is believed to activate TAAR1 (trace amine-associated receptor 1) in addition to 5-HT1A (serotonin 1A) receptors.
“The results of this first placebo-controlled study assessing the utility of SEP-363856 in patients with schizophrenia are exciting, and we intend to advance the development of this novel investigational medicine as quickly as possible,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “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.”
SEP-363856 is a psychotropic agent with a novel, non-D2 mechanism of action, distinct from currently marketed antipsychotics. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. SEP-363856 was optimized for antipsychotic activity based on quantitative structure-activity relationship analysis. SEP-363856 is jointly owned by Sunovion and PsychoGenics, and Sunovion has exclusive rights to develop and commercialize SEP-363856 globally.
SEP-363856 is being studied in a global development program for schizophrenia as well as for Parkinson’s disease psychosis, with additional indications under consideration. Clinical trial results to date demonstrate a predictable pharmacokinetic profile suitable for once daily use.
“We believe that the results from this study illustrate the promise of the PsychoGenics’ target-agnostic approach using the SmartCube platform,” added Eric Nestler, M.D., Ph.D., Director of the Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai and Chairman of the PsychoGenics Scientific Advisory Board. “We look forward to continuing our work with Sunovion in identifying compounds that have the potential to make a significant difference for patients.”