SEP-363856 was discovered by Sunovion in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and the artificial intelligence algorithms associated with it.
Its breakthrough therapy designation was granted based on data from a phase 2 trial, called SEP361-201 and also from the SEP361-202 open-label, safety and tolerability extension study.
The SEP 361-201 trial achieved its primary endpoint by showing that hospitalized patients with acute exacerbation of schizophrenia treated with SEP-363856 had statistically significant and clinically meaningful improvement in the positive and negative syndrome scale (PANSS) total score in comparison to placebo following four weeks of treatment.
As per the assessment on the Clinical Global Impression Scale – Severity (CGI-S), patients in the SEP-363856 arm also had improvement in the overall severity of illness.
Courtesy of the breakthrough therapy designation, the psychotropic agent becomes eligible for FDA’s intensive guidance on its development program and also for priority review.
Schizophrenia is a brain disorder that is chronic, serious and can also be severely disabling. The FDA’s breakthrough therapy designation is for fast tracking the development and review of drugs for serious or life-threatening conditions such as schizophrenia when preliminary clinical evidence suggest that the drug could demonstrate substantial improvement over existing therapy on at least one clinically significant endpoint.
Sunovion president and CEO Antony Loebel said: “Breakthrough Therapy Designation underscores the potential of SEP-363856 as a novel treatment for patients with schizophrenia, for whom few major advances in treatment have occurred since the advent of antipsychotic pharmacotherapy in the 1950s.
“Investigational studies to further evaluate the clinical benefit of SEP-363856 are in progress, and we look forward to working closely with the FDA on this important potential new therapy.”
In addition to schizophrenia, SEP-363856 is being evaluated for Parkinson’s disease psychosis, with more indications under review. Till date, clinical trial results for the investigational drug have shown a predictable pharmacokinetic (PK) profile suitable for daily once use.