Business
Minerva Neurosciences Reports First Quarter 2020 Financial Results and Business Updates
Top line results from pivotal Phase 3 trial with roluperidone in negative symptoms in patients diagnosed with schizophrenia on track for release in second
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Top line results from pivotal Phase 3 trial with roluperidone in negative symptoms in patients diagnosed with schizophrenia on track for release in second quarterWALTHAM, Mass., May 04, 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 March 31, 2020. “We are pleased to report that we are approaching the conclusion of the double-blind, 12-week phase of our pivotal Phase 3 trial with roluperidone and reiterate our previous guidance that we expect to report top line results in the second quarter,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “Progress in this trial has been unaffected to date by the coronavirus pandemic and we are continually monitoring each trial site and our contract research organizations to ensure the safety of all patients and their access to study drug,” said Dr. Luthringer. “The last patient visit has taken place in the double-blind phase of the trial, in which a total of 515 patients were enrolled. In total, 362 patients have completed the double-blind phase, 333 patients from the double-blind phase have elected to transition into the open-label extension period, and 92 patients have completed the extension phase as of April 30, 2020. “Finally, the prominent role of negative symptoms in schizophrenia has been increasingly highlighted by the key opinion leader (KOL) community since we initiated the Phase 3 trial,” said Dr. Luthringer. “Our recent KOL webcast, which included the participation of Dr. Stephen Marder, Dr. William Carpenter, Dr. Ofer Agid and Dr. John Kane, discussed how roluperidone may play an important role in treating the negative symptoms of schizophrenia, which persist and worsen over the lifetimes of the majority of patients, accounting for their functional disability and severely limiting their social and vocational reintegration over the long term.” Clinical Development Updates Roluperidone (MIN-101): Following the completion of enrollment in a pivotal Phase 3 trial with roluperidone (clinicaltrials.gov identifier: NCT033971340) to treat negative symptoms in schizophrenia in February 2020, top-line results from this tria...