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- ex-{num}
- exhibit {num}
- contact :
- william b . boni
- vp , investor relations /
- {enum} communications
- minerva neurosciences , inc .
- {enum} {num}-{num}
- for immediate release
- minerva neurosciences provides update on min-{num} and min-{num} clinical programs
- last patient completes extension phase of phase iib trial with min-{num}
- company receives fda acceptance of investigational new drug application for min-{num}
- waltham , ma , september {num} {num} – minerva neurosciences , inc . ( nasdaq : nerv ) , a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system ( cns ) disorders , today announced recent progress in its clinical programs with min-{num} for schizophrenia and with min-{num} for major depressive disorder ( mdd ) .
- min-{num}
- the last patient has completed the {num}-week open-label extension period of the company's phase iib clinical trial of min-{num} in patients with negative symptoms of schizophrenia . positive results from the prospective {num}-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 {num} milligrams ( mg ) and {num} mg daily doses of min-{num} compared to placebo . statistically significant benefit of min-{num} was also demonstrated in multiple secondary endpoints .
- approximately {num} 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-{num} 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 {num} and the company expects to announce top line results from this phase in the fourth quarter of {num} 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 the united states and europe in preparation for phase 3 testing of min-{num} which is expected to begin in {num}
- min-{num} is a drug candidate with equipotent affinities for sigma 2 and 5-hydroxytryptamine-2a ( 5-ht 2a ) and lower affinity at a1-adrenergic receptors . min-{num} 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-{num}
- the u . s . food and drug administration ( fda ) has accepted the company's investigational new drug ( ind ) application to begin clinical testing of min-{num} in the united states . this acceptance follows positive results from a randomized , double-blind , placebo- and positive-controlled phase iia clinical trial in mdd with min-{num} in europe announced earlier this year . data from the study demonstrated the dose-dependent superiority of min-{num} over placebo in reducing symptoms of depression and anxiety .
- fda acceptance of the ind for min-{num} allows the company to begin clinical trials with this compound in the u . s . , building upon the results from the european trial . planning is underway for these trials , which are expected to begin in {num}
- min-{num} 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 minerva neurosciences
- 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-{num} which recently completed a phase iib clinical trial for schizophrenia ; min-{num} which recently completed a phase iia clinical trial development for mdd ; min-{num} ( jnj-{num} ) , which recently completed phase iia and phase ib clinical trials for insomnia and mdd , respectively ; and min-{num} in pre-clinical development for parkinson's disease . minerva's common stock is listed on the nasdaq global market under the symbol " nerv . " for more information , please visit www . minervaneurosciences . com .
- 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 {num} 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-{num} and min-{num} ; the clinical and therapeutic potential of min-{num} and min-{num} ; our ability to successfully develop and commercialize min-{num} and min-{num} ; 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-{num} and min-{num} will advance further in the clinical trials process and whether and when , if at all , they will receive final approval from the u . s . food and drug administration or equivalent foreign regulatory agencies and for which indications ; whether the results of future clinical trials of min-{num} and min-{num} if any , will be consistent with the results of past clinical trials ; whether min-{num} and min-{num} will be successfully marketed if approved ; whether our therapeutic product discovery and development efforts with min-{num} and min-{num} will be successful ; our ability to achieve the results contemplated by our co-development agreements ; management's ability to successfully achieve its goals ; our ability to raise additional capital to fund our operations on terms acceptable to us ; and general economic conditions . 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 securities and exchange commission , including our quarterly report on form {num}-q for the quarter ended june {num} {num} filed with the securities and exchange commission on august {num} {num} copies of reports filed with the sec are posted on our website at www . minervaneurosciences . com . the forward-looking statements in this press release are based on information available to us as of the date hereof , and we disclaim any obligation to update any forward-looking statements , except as required by law .
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