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Sunovion begins phase 2 study of psychotropic agent for psychosis
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Sunovion Pharmaceuticals Inc. recently announced the initiation of a global phase 2 program for SEP-363856, a psychotropic agent with a non-D2 mechanism of action, for psychosis in schizophrenia and Parkinson’s disease.
Preclinical analysis indicated SEP-363856 as a potential treatment for positive and negative symptoms of schizophrenia and hallucinations and delusions in Parkinson’s disease.
Translational findings from phase 1 studies provided further support for SEP-363856 among individuals with schizophrenia and healthy controls.
The phase 2 program includes the following studies:
- A 4-week, randomized, double-blind, parallel-group, placebo controlled, flexibly-dosed multicenter study to assess efficacy and safety among adults with acute psychosis and schizophrenia;
- A 26-week open-label safety and tolerability extension study in adults with schizophrenia; and
- A randomized, parallel group, multicenter study to assess efficacy, safety and tolerability among individuals with Parkinson’s disease psychosis.
“With its differentiated mechanism of action and in vitro activity, we believe that SEP-363856 has the potential to be an important therapeutic option,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in a press release. “The advancement of SEP-363856 demonstrates Sunovion’s ongoing commitment to address serious psychiatric and neurological conditions, and we appreciate the support of the patients and health care providers who are participating in these clinical studies.”