WALTHAM, Mass., March 15, 2018 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq:NERV), a biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will host a Key Opinion Leader (KOL) meeting on the topic of Negative Symptoms of Schizophrenia on Thursday, March 22, 2018 in New York City.
The event will feature presentations by KOLs Ofer Agid, MD, Centre for Addiction and Mental Health, University of Toronto, and Thomas Laughren, MD, former Division Director, Division of Psychiatry Products, CDER, who will discuss the current pharmacological treatment strategies to address positive and negative symptoms of schizophrenia, as well as the regulatory path for novel compounds that address negative symptoms. Both Dr. Agid and Dr. Laughren will be available to answer questions at the conclusion of the event.
Members of Minerva's management team will further discuss the evolving paradigm in the diagnosis and pharmacological treatment of negative symptoms in schizophrenia and beyond. They will review the clinical development of roluperidone (MIN-101) for the treatment of negative symptoms of schizophrenia and the design of the Phase 3 clinical trial with this compound.
Dr. Agid is a Clinician Scientist and Psychiatrist in the Schizophrenia Program and Medical Leader of the Home Intervention for Psychosis (HIP) team at the Centre for Addiction and Mental Health. He is also Associate Professor in the Department of Psychiatry at the University of Toronto. Dr. Agid’s research focus is psychopharmacology in schizophrenia, specifically early response to antipsychotic medications and early predictors of response. His work has uncovered a new “early onset of action” hypothesis of antipsychotics, which has impacted current practice guidelines for the treatment of schizophrenia. As the medical leader of the HIP team, Dr. Agid initiated an algorithm-based treatment approach for first-episode schizophrenia while collecting extensive clinical data regarding treatment response. This algorithm was implemented in order to optimize antipsychotic treatment during the earliest stages of the illness, a critical time period in terms of longer-term outcomes. This systematic and standardized approach has resulted in a large and comprehensive database; the published data to date have provided clear, empiric evidence that clinicians can use in approaching the pharmacological management of first-episode schizophrenia. It has also challenged current practice patterns and proven valuable in examining trajectories of response. In addition, Dr. Agid is involved in investigating patterns of non-adherence and examining value systems and happiness in schizophrenia, with an emphasis on the relationship to, and influence on, functional outcomes.
Dr. Laughren is currently a consultant in psychiatric drug development. He recently retired as Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA. Prior to joining FDA in September, 1983, Dr. Laughren was affiliated with the VA Medical Center in Providence, RI, and was on the faculty of the Brown University Program in Medicine. He received his medical degree from the University of Wisconsin in Madison, Wisconsin, and also completed residency training in psychiatry at the University of Wisconsin. Dr. Laughren is board certified in general psychiatry. As Division Director for the Division of Psychiatry Products, Dr. Laughren oversaw the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. He has authored and co-authored many papers and book chapters on regulatory and methodological issues pertaining to the development of psychiatric drugs and is a frequent speaker at professional meetings on these same topics. Dr. Laughren has received numerous awards for his regulatory accomplishments.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay of the event will be accessible here.
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: roluperidone (MIN-101), in Phase 3 clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in Phase 2b clinical development for insomnia and major depressive disorder (MDD); MIN-117, planned to begin Phase 2b clinical development for MDD in early 2018; and MIN-301, 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 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 potential of the diagnosis and treatment of negative symptoms in schizophrenia and other diseases; the timing and scope of future clinical trials and results of clinical trials; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize our therapeutic products. 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 roluperidone, seltorexant, MIN-117 and MIN-301 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 any of our therapeutic product discovery and development efforts will be successful; 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 Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 12, 2018. 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.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376