Minerva Provides Year-End Update on Clinical Trials With Three Central Nervous System Product Candidates
"Our primary focus during 2015 has been on clinical trial execution, and we are pleased with the pace of patient recruitment that has taken place in all four ongoing trials," said Dr.
MIN-101
In the randomized, placebo-controlled double-blind Phase IIb trial with MIN-101 for schizophrenia, the Company has reached its patient screening target and expects to achieve its enrollment target of 234 patients in late December, 2015. The primary objective of this trial is to evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenic patients over 12 weeks of treatment. Patients who respond positively to treatment with MIN-101 will have the opportunity to enter an extension period of six months, during which all patients will be on active treatment. Topline results for the core 12-week treatment evaluation period are expected in the second quarter of 2016.
MIN-202 (JNJ-42847922)
Patient enrollment has been completed in two trials with MIN-202, under joint development with
The Phase IIa trial in insomnia disorder is a randomized, placebo-controlled double-blind study to evaluate treatment with MIN-202 in 26 patients with insomnia disorder without psychiatric co-morbidity. The primary endpoint is sleep efficiency as measured by polysomnography, with secondary endpoints including additional assessments of sleep, mood and cognition, as well as safety.
The Phase Ib trial in adjunctive treatment of MDD is a randomized, diphenhydramine- and placebo-controlled double-blind trial to evaluate treatment with MIN-202 in 48 patients with MDD. The primary endpoint is safety, and secondary endpoints include assessments of depressive symptomology, cognition and sleep.
MIN-117
The Company is continuing to screen and randomize patients in a Phase IIa trial with MIN-117 to treat MDD. The trial is comparing the therapeutic impact of two doses of MIN-117 to paroxetine and placebo. Target enrollment is 80 patients, with 20 patients expected in each of the four groups. The primary endpoint is the efficacy of MIN-117 versus placebo in reducing depressive symptoms. Topline results are expected in the first half of 2016.
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Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and results of future clinical milestones; the timing of future clinical trials and results of clinical trials; the clinical and therapeutic potential of our compounds; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management's ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and
may differ materially from actual results due to a variety of factors including, without limitation, our ability to successfully enroll patients in ongoing and future clinical trials; the safety and efficacy of our product candidates observed in clinical development; our ability to accurately forecast the costs associated with ongoing and future clinical trials; and our ability to raise additional capital to fund our operations on terms acceptable to us or at all. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption "Risk Factors" in our filings with the
CONTACT:William B. Boni VP, Investor Relations/ Corp. CommunicationsMinerva Neurosciences, Inc. (617) 600-7376
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