APA House Call: SEP-363856 for Schizophrenia


The novel target therapy has reported promising early findings. What is its potential?

John Krystal, MD

John Krystal, MD

The 2020 American Psychiatric Association (APA) Annual Meeting was cancelled this year, with plans made to convert the world-leading psychiatry conference into a two-part virtual session and educational platform for attendees.In lieu of regular on-site coverage, HCPLive® will be running a series of interviews, insights, and reporting on topics that frequently headline the APA meeting—featuring familiar experts.

What would a novel-targeting schizophrenia drug mean for the field?

For the case of investigative candidate SEP-363856, it may mean a broader improvement of symptoms, without a sacrifice of safety.

New data from the randomized, controlled trial assessing the efficacy and safety of SEP-363856 in adults with schizophrenia show the Sunovion drug candidate reduced symptoms versus placebo over 4 weeks.

The findings show the non-dopamine D2-receptor-binding oral compound might provide significant benefit for schizophrenia symptoms from a mechanism that deviates from common antipsychotic therapies.

“SEP-363856 does not block the dopamine receptors themselves, so it has the possibly to produce benefit—maybe even more benefit—with a different profile of tolerability,” explained John Krystal, MD.

In an interview with HCPLive, Krystal, the chair of Psychiatry at Yale University, detailed the discovery of the oral compound, its animal-model benefits which inspired the assessment of schizophrenia care, and how the drug’s targeting of trace amine-associated receptor 1 (TAAR1) and 5-hydroxytrypatimine type 1A (5-HT1A) receptor differentiates the mechanism of care in patients.

“It seemed to do a lot better than placebo, and not block the dopamine D2-receptor,” Krystal said. “That makes it, hopefully, the first medication that we’ll have in our toolbox to treat schizophrenia that does not block the dopamine D2-receptor.”

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