WALTHAM, Mass.—Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders, has announced positive top-line results from a Phase 1b clinical trial in major depressive disorder (MDD) with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV.
“Treatment with MIN-202 was observed to result in consistent improvements in the symptoms of depression in MDD patients in this trial,” said Dr. Remy Luthringer, president and CEO of Minerva. “The results pave the way to initiate a Phase 2b trial in patients suffering from MDD. These improvements support the potential of MIN-202 to have a direct effect on mood independent from its effect on sleep. We previously observed that MIN-202 had a significant effect on sleep in our Phase 2a trial in patients suffering from insomnia disorder.”
The Phase 1b trial was a randomized, multi-center, double-blind, parallel group, diphenhydramine- and placebo-controlled study to evaluate the effect of MIN-202 in MDD outpatients 18-65 years of age. Forty-eight participants were enrolled in three groups that received doses of 20 milligrams (mg) of MIN-202 daily, 25 mg of diphenhydramine (DPH) daily (used as a positive control to induce sedation) or placebo over four weeks.
MIN-202 was observed to be well tolerated by study participants over a one-month treatment duration, with no new emerging safety signals and no serious adverse events.
Consistently greater improvements in depressive symptomatology were observed in patients randomized to receive MIN-202 compared to those randomized to receive placebo (PLA) or diphenhydramine (DPH), as measured by clinician administered rating scales, including the Hamilton Depression Rating Scale (HDRS17). Core symptoms of depression (as measured by the HAM-D6) were observed to be significantly improved in the MIN-202 arm when compared with the PLA arm.
The primary endpoint was safety and tolerability, and secondary endpoints included assessments of depressive symptomatology, cognition and sleep. The trial was conducted at seven clinical sites in Europe. Only top line results with respect to safety, tolerability and efficacy on depressive symptomatology are reported in this press release. Complete results are planned for peer-reviewed presentation in the future.
MIN-202 is also under development to treat primary insomnia disorder. Recently announced top line data from a Phase 2a trial in this indication included statistically significant improvements in sleep efficiency (SE) as measured by objective polysomnography, the primary endpoint of the trial, observed in study patients treated with MIN-202, with an acceptable safety and tolerability profile, compared to patients treated with placebo.
Minerva entered into a co-development and license agreement with Janssen in February 2014 covering MIN-202 and other orexin-2 compounds. Under this agreement, Minerva has an exclusive license to these compounds in the European Union, Switzerland, Liechtenstein, Iceland and Norway. Janssen has exclusive rights to these compounds worldwide outside of these territories.
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of products to treat CNS diseases. Minerva’s proprietary compounds include: MIN-101, in Phase 2b development for schizophrenia; MIN-202 (JNJ-42847922), in Phase 2a and Phase 1b development for insomnia and adjunctive treatment of MDD, respectively; MIN-117, in Phase 2a development for MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.”