Biopharmaceutical company Minerva Neurosciences has completed patient enrolment in a Phase III multi-cantered clinical trial of roluperidone for the treatment of schizophrenia disorder.
Roluperidone is the company’s major product for treating patients identified with negative symptoms in schizophrenia.
The 12-week trial is being conducted at clinical sites in the US and Europe. It involved the participation of 515 students.
It is designed as a randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of 32mg and 64mg doses of roluperidone.
The trial has achieved its primary endpoint as measured under the Marder negative symptoms factor score of the Positive and Negative Syndrome Scale.
According to Minerva, the secondary endpoints achieved include the Personal and Social Performance (PSP) Scale and Clinical Global Impression of Severity (CGI-S).
The biopharmaceutical firm noted that the patients are being randomised in 1:1:1 ratio and are receiving 32mg and 64mg doses of roluperidone and placebo, respectively.
Minerva said in a press statement: “The core 12-week double-blind phase of the trial is followed by a 40-week, open-label extension period during which patients on the drug continue receiving their original dose and patients on placebo receive one of the two doses of roluperidone.”
Data readout from the 12-week double-blind phase of the trial is expected in the second quarter of this year.
Minerva executive chairman and CEO Remy Luthringer said: “The completion of patient enrollment marks a major milestone in the Phase III trial with roluperidone.
“We believe the data from this trial have the potential to lead to a significant new treatment option for schizophrenia, as no pharmacological agent is approved to treat negative symptoms, which is the single greatest unmet need for patients with this disease, their families and their physicians.”
