WALTHAM, Massachusetts, August 3, 2020 (GLOBE NEWSWIRE) – Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-level biopharmaceutical corporation targeting the progression of treatments for central nerve formula disorders (CNS), launched key trade updates and monetary effects for the quarter ended June 30, 2020.
Clinical pipe upgrade
Roluperidone
On May 29, 2020, the company announced that the Roluperidone Phase 3 trial to treat negative symptoms of schizophrenia had not reached its number one point (reduction of the Marder PANSS or NSFS negative symptom factor score) and key secondary (improvement of -public functionality and social scale total score or PSP).
Patients receiving active remedy showed numerically impressive innovations in NSFS compared to placebo, and a higher number of responders measured through NSFS and overall PANSS scores were observed in roluperidone remedy groups. Relief in negative symptom scores in the 64 mg arm of roluperidone resulted in a functional improvement measured through PSP.
Roluperidone was well tolerated and knowledge of Phase 3 protection was consistent with those of the Phase 2b study.
“We are conducting our in-depth research into the Phase 3 trial with Roluperidone and will touch the U.S. Food and Drug Administration to request an assembly to discuss our plans for the next steps in roluperidone clinical progression,” said Dr. Remy Luthringer, ceo and CEO of Minerva. “Although the trial did not reach its number one endpoint due, in our opinion, to a higher response to unexpected placebo, we are encouraged by the effects of the study. The consistency of relief in general negative symptoms and the maximum subtypes of those symptoms is similar to that observed in the past Phase 2b study.
“Integrated research into Phase 2b and Phase 3 knowledge shows a very significant separation between the two doses of roluperidone and placebo throughout the remedy period,” Dr. Luthringer said. “We believe that improved negative symptoms and resulting functional improvement help the prospective roleuperidone. This discovery will help FDA consultations regarding this possible remedy of negative symptoms, which remain one of the maximum vital reasons for daily disability and A Critical Need Unmet for patients with this disease.
On July 1, 2020, the Company announced that it had exercised its right to withdraw from its agreement with Janssen Pharmaceutica NV (Janssen) for the long-term progression of seltorexant (MIN-202). As a result, the Company will collect a royalty on seltorexant’s global sales on all indications between the two digits, without monetary legal liability for Janssen.
“With respect to seltorexant, the resolve to withdraw from our agreement with Janssen at this level of the program allows us a significant monetary interest in the long-term profit flow of a compound with significant advertising prospective while freeing ourselves from the company’s monetary obligations for a truly extensive Phase 3 program that encompasses primary depressive disorders and insomnia.” Dr. Luthringer said. “In addition, retirement will help align our human and monetary resources with our number one goal of defining a path to the approval of our number one compound, roluperidone.”
Second Quarter 2020 Financial Results
Information on the convening of the convention:
The live stream will be held in “Events and Presentations” in the Investors and Media segment of Minerva’s online page in ir.minervaneurosciences.com. The archived web stream will be made on the online page approximately two hours after the occasion for 90 days.
About Minerva Neurosciences:
Minerva’s composite portfolio includes: roluperidone (MIN-101), in clinical progression for schizophrenia; possible flow of seltorexant royalties (MIN-202 or JNJ-42847922), in clinical progression for insomnia and CT; and MIN-301, in preclinical progression for Parkinson’s disease. Minerva’s non-unusual stocks are indexed on the nasdaQ global market under the symbol “NERV”. For more information, visit www.minervaneurosciences.com.
Safe Harbor Future Statement
Contact: William B. BoniVP, Investor Relations / Corp. Communications Minerva Neurosciences, Inc. (617) 600-7376