Publication of roluperidone phase III study results for treatment of negative symptoms of schizophrenia in Schizophrenia Bulletin.

The study authors conclude that this study confirms the potential of roluperidone to treat the negative symptoms in individuals with schizophrenia as well as improve everyday functioning.

The publication, entitled, “Efficacy and Safety of Roluperidone for the treatment of negative symptoms of schizophrenia,” reports on the Phase III placebo-controlled multi-national trial of roluperidone, a compound with antagonist properties for 5-HT2A, sigma2 and 1A-adrenergic receptors, targeting negative symptoms in patients with schizophrenia. The goal of the trial was to confirm the findings of a previous Phase II trial with a similar patient population and methodology that had demonstrated roluperidone superiority over placebo.

The Company previously disclosed results of the Phase III trial of roluperidone in May 2020 and open-label results in May 2021. The Phase III study included 513 patients with schizophrenia with moderate to severe negative symptoms. Study patients were administered either 32 mg/day of roluperidone, 64 mg/day of roluperidone, or placebo for 12 weeks. The primary endpoint was the PANSS-derived Negative Symptom Factor Score (NSFS) and the key secondary endpoint was Personal and Social Performance scale (PSP) total score.

The study found that NSFS scores improved (were lower) for patients receiving roluperidone 64 mg compared to placebo. The intent-to-treat (ITT) analysis data set marginally missed statistical significance, but reached nominal significance (p=0.044) for the modified-ITT (m-ITT) data set. Changes in PSP total score were statistically significantly better on roluperidone 64 mg compared to placebo for both ITT and m-ITT (p =0.021 and p=0.017, respectively).

About roluperidone; On November 3, 2021, Minerva Neurosciences announced that the FDA denied the company’s request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy for the treatment of negative symptoms in schizophrenia. A Type C meeting is scheduled. Subject to the timing of and feedback from the FDA, Minerva continues to plan for the submission of a New Drug Application (NDA) in the first half of 2022.

On September 30, 2021, the Company completed and announced results from a pivotal bioequivalence study comparing the roluperidone formulations used in its late-stage Phase IIb and Phase III trials and the planned commercial formulation. The planned commercial formulation was tested under both fasted and fed conditions. The study met key pharmacokinetic (PK) objectives, and the data demonstrate bioequivalence across the various formulations.

See-"Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia"; Michael Davidson, Jay Saoud, Corinne Staner, Nadine Noel, Sandra Werner ... Schizophrenia Bulletin, sbac013, https://doi.org/10.1093/schbul/sbac013 Published: 25 February 2022.