Minerva Neurosciences MIN-202 Well-Tolerated in Phase I Clinical Study in Japanese Patients

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Minerva Neurosciences, Inc.
NERV
today announced top line results from a Phase I clinical trial conducted in Japan with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV. It was observed that single dose morning administration of MIN-202 was well tolerated at all three dose levels tested, 5 milligrams (mg), 20 mg and 40 mg.  The observed plasma pharmacokinetic features were comparable to those observed in previous studies carried out in healthy non-Asian study participants. No clinically relevant safety concerns were observed based on the assessment of multiple safety endpoints. Somnolence was the most frequently reported adverse event at the two higher doses, an expected finding as this compound is being developed as a treatment for patients suffering from insomnia disorder and as adjunctive treatment to concomitant antidepressant drug therapy in major depressive disorder (MDD).  "These findings are an important step in the global development of MIN-202," said Dr. Remy Luthringer, president and chief executive officer of Minerva.  "They add to the expanding database of
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