Last patient completes extension phase of Phase IIb trial with MIN-101
Company receives
MIN-101
The last
patient has completed the 24-week open-label extension period of the Company’s Phase IIb clinical trial of MIN-101 in patients with negative symptoms of schizophrenia. Positive results from the prospective 12-week randomized, double-blind, placebo-controlled core phase of this trial were announced previously. These results from the core phase demonstrated statistically significant improvement of negative symptoms, the primary endpoint of the trial, in patients treated with both 32 milligrams (mg) and 64 mg daily doses of MIN-101 compared to placebo. Statistically significant benefit of MIN-101 was also demonstrated in multiple secondary endpoints.
Approximately 140 patients who completed the core phase of this trial entered the extension phase, during which all patients received one of the two doses of MIN-101. Patients who received placebo in the core study were
randomized to one of these doses. As planned, the extension phase of the trial was completed in the third quarter of 2016, and the Company expects to announce top line results from this phase in the fourth quarter of 2016. The Company has submitted results from the core phase of the trial for peer-reviewed publication and presentations and plans to meet with regulatory authorities in
MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5-hydroxytryptamine-2A (5-HT2A) and lower affinity at alpha1-adrenergic receptors. MIN-101 has no direct dopaminergic post-synaptic blocking effects, known to be involved in some side effects like
extrapyramidal symptoms, sedation, prolactin increases and weight gain.
MIN-117
The
begin clinical trials with this compound in the
MIN-117 is an antidepressant drug candidate with a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine transporters.
About
which recently completed a Phase IIb clinical trial for schizophrenia; MIN-117, which recently completed a Phase IIa clinical trial development for MDD; MIN-202 (JNJ-42847922), which recently completed Phase IIa and Phase Ib clinical trials for insomnia and MDD, respectively; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the
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 with MIN-101 and MIN-117; the clinical and therapeutic potential of MIN-101 and MIN-117; our ability to successfully develop and commercialize MIN-101 and MIN-117; 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, whether MIN-101 and MIN-117 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from
the
caption “Risk Factors” in our filings with the
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
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