Treatment with selective orexin-2 receptor antagonist observed to be well tolerated and to improve symptoms of depression, independent from its effect on sleep
"Treatment with MIN-202 was observed to result in consistent improvements in the symptoms of depression in MDD patients in this trial," said Dr.
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 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
MIN-202 is also under development to treat primary insomnia disorder. Recently announced top line data from a Phase IIa 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
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 final data from the Phase Ib MIN-202 trial will be consistent with the preliminary results, 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
William B. BoniVP, Investor Relations/ Corp. Communications Minerva Neurosciences, Inc.(617) 600-7376
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