Business
Minerva Neurosciences Reports Fiscal 2020 Fourth Quarter and Year End Financial Results and Business Updates
Phase 3 open-label extension completed on schedule in patients with negative symptoms of schizophrenia and data will be available in H1 2021 Minerva’s royalty
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Phase 3 open-label extension completed on schedule in patients with negative symptoms of schizophrenia and data will be available in H1 2021 Minerva’s royalty interest in seltorexant acquired by Royalty Pharma for an upfront payment of $60 million and up to $95 million in additional payments contingent on certain clinical, regulatory and commercialization milestones Cash, cash equivalents and restricted cash at December 31, 2020 of $25.5m and $60m upfront payment received from Royalty Pharma in January 2021 fund current development plans WALTHAM, Mass., March 08, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system disorders, today reported key business updates and financial results for the fourth quarter and fiscal year ended December 31, 2020. Program Updates Roluperidone Roluperidone, a proprietary orally dosed molecule acting on 5HT2A, Sigma2, and α‑adrenergic receptors, is Minerva’s lead product candidate currently being evaluated in a Phase 3 study as a potential treatment for negative symptoms of schizophrenia. Following completion of the 12-week double-blind phase of the Phase 3 study in H1 2020, a total of 333 patients (65%) entered the 9-month open-label extension in which those patients already being treated with roluperidone remained on treatment on the same dose received in the 12-week double-blind phase (32mg or 64mg) and those patients who received placebo in the 12-week double-blind phase were randomized to either 32mg or 64mg. Patient evaluation in the open-label extension phase of the Phase 3 trial of roluperidone was achieved on schedule on February 15, 2021, with a total of 202 patients (61%) completing this phase. Data are expected to be available in the first half of 2021. The Company expects the data from the open-label extension will demonstrate whether: improvement of negative symptoms is sustained or increased over the one-year duration;improvement of negative symptoms leads to improved functioning;roluperidone maintains or improves positive symptoms and/or agitation; andthe safety and tolerability profile of roluperidone is maintained over the one-year administration period. The Company intends to initiate a pivotal bioequivalence study in approximately 48 health...