Patients with schizophrenia demonstrated improvement on a scale used to measure symptom severity after taking a drug being tested in a clinical trial, according to an article published online in the New England Journal of Medicine.
The article, co-authored by John H. Krystal, MD, Robert L. McNeil, Jr. Professor of Translational Research and Chair of the Yale Department of Psychiatry at Yale School of Medicine, notes that patients who took the once-daily drug SEP-363856 demonstrated statistically significant and clinically meaningful improvement in their symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) compared to placebo after four weeks of treatment.
Patients also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale and all major PANSS subscales. The article indicates that the drug was well tolerated throughout the study.
Sunovion Pharmaceuticals Inc. 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.. It is being studied in a global Phase 3 development program for schizophrenia with additional indications under consideration. The U.S. Food and Drug Administration granted Breakthrough Therapy Designation for SEP-363856 for schizophrenia in May 2019.
Krystal said the data produced by the study represents an exciting step forward in schizophrenia research.
“The steps that led to identifying this new mechanism of action, targeting (the receptor) TAAR1, were very novel and they reflected a courageous and innovative approach by Sunovion to identifying new ways to treat schizophrenia,” Krystal said. “For the last 60 years, antipsychotics that bind to dopamine receptors have been the standard of care despite their side effect profile. It is my hope that these results for SEP-363856 support a new schizophrenia treatment for people who have been diagnosed with this serious mental health condition. SEP-363856 could have a big impact on people with schizophrenia, their families, and on the public health burden posed by schizophrenia.”
Publication of the study’s findings in the New England Journal of Medicine demonstrates the potential of the drug to be the first TAAR1 agonist for the treatment of schizophrenia, said Kenneth Koblan, PhD, Chief Scientific Officer of Sunovion.
“This innovative approach to the treatment of schizophrenia may provide a completely new option for the 23 million people worldwide who live with this serious mental health condition,” he said.
As noted in the journal, in the six-month, open-label extension study, SEP-363856 demonstrated continued improvement across efficacy measures and appeared to be safe and well-tolerated.