Business
Minerva Neurosciences Reports Second Quarter 2020 Financial Results and Business Updates
WALTHAM, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"WALTHAM, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended June 30, 2020.\n Clinical Pipeline Update Roluperidone On May 29, 2020, the Company announced that the Phase 3 trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary (reduction in PANSS Marder Negative Symptoms Factor Score or NSFS) and key secondary (improvement in the Personal and Social Performance Scale Total Score or PSP) endpoints. Although limited inferences can be drawn from these data, unadjusted statistically significant separations from placebo were observed in NSFS at Week 4 for both doses and at Week 8 for the 64 mg dose. The 64 mg dose was statistically significantly different from placebo as measured by change in PSP at all other assessment timepoints. The patients receiving active treatment showed numerically superior improvements in NSFS to placebo, and a higher number of responders as measured by NSFS and total PANSS scores was observed in the roluperidone treatment groups. The reduction in negative symptoms scores in the 64 mg arm of roluperidone translated into functional improvement as measured by PSP. Roluperidone was generally well tolerated, and Phase 3 safety data were consistent with such data from the Phase 2b trial. “We continue our in-depth analyses of the Phase 3 trial with roluperidone and will be contacting the U.S. Food and Drug Administration to request a meeting to discuss our plans regarding the next steps in the clinical development of roluperidone,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “Although the trial did not meet its primary endpoint due, we believe, to an unexpected high placebo response, we are encouraged by the study results. The consistency of reduction in overall negative symptoms and in the most important subtypes of these symptoms is similar to that observed in the previous Phase 2b study.” “The integrated analysis of the Phase 2b and Phase 3 data show a highly significant separation between the two doses of roluperidone and placebo throughout the treatment period,” said Dr. Luthringer. “We believ...