Minerva Neurosciences Provides Update on Clinical Development Program With MIN-202, Selective Orexin-2 Receptor Antagonist
"We are pleased with the progress that is being made in the development of MIN-202 in insomnia and adjunctive MDD," said Dr.
Insomnia trial (clinicaltrials.gov identifier: NCT02464046):
The Phase 2a trial in insomnia disorder is a randomized, placebo-controlled double-blind study to evaluate treatment with MIN-202 in subjects with insomnia disorder without psychiatric co-morbidity. It is estimated that 26 patients will be enrolled. Half of these patients will receive MIN-202 for five days, followed by a washout period and then placebo for five days. The other half will receive placebo first, followed by a washout period and then MIN-202 under the same schedule.
The primary endpoint of this trial is sleep efficiency as measured by polysomnography, and secondary endpoints include additional assessments of sleep, mood and cognition, as well as safety. The trial is being conducted at clinical sites in the U.S. and
Adjunctive MDD trial (clinicaltrials.gov identifier: NCT02476058):
The Phase 1b trial in adjunctive MDD is a randomized, diphenhydramine- and placebo-controlled double-blind study to evaluate treatment with MIN-202 in subjects with MDD. It is estimated that 48 patients will be enrolled in three groups, which will be treated with MIN-202, diphenhydramine and placebo, respectively, while maintained on their antidepressant regimens.
The primary endpoint of this trial is safety, and secondary endpoints include assessments of depressive symptomology, cognition and sleep. The trial is being conducted at clinical sites in
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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 regarding MIN-202; the timing of future clinical trials and results of clinical trials regarding MIN-202; the clinical and therapeutic potential of MIN-202; our ability to successfully develop and commercialize MIN-202; 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 only predictions and may
differ materially from actual results due to a variety of factors including, without limitation, whether MIN-202 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the
CONTACT:Source:William B. Boni VP, Investor Relations/ Corp. CommunicationsMinerva Neurosciences, Inc. (617) 600-7376
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