Multi-center trial to enroll approximately 324 patients at approximately 40 clinical sites in U.S. and Europe
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced the screening of the first patient in a Phase 2b trial of MIN-117 (Study MIN-117C03) to reduce the symptoms of patients diagnosed with major depressive disorder (MDD).
The primary objective of the trial is to evaluate the efficacy of two fixed doses of MIN-117, 5.0 milligrams (mg) and 2.5 mg, compared with placebo in reducing the symptoms of major depression as measured by the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score over six weeks of treatment. Secondary objectives include: (1) assessment of the change from baseline in symptoms of anxiety using the Hamilton Anxiety Scale (HAM-A); (2) the change in severity of illness using the Clinical Global Impression of Severity Scale (CGI-S) and Clinical Global Impression of Improvement Scale (CGI-I); and (3) safety over six weeks of treatment.
“While existing therapies for MDD are available, their effectiveness is limited due to unacceptable side effects, particularly cognitive impairment and sexual dysfunction,” said Dr. Remy Luthringer, Chief Executive Officer of Minerva. “These shortcomings warrant the exploration of new treatment strategies with molecules such as MIN-117 that possess an innovative and rich pharmacological profile. In addition to the primary endpoint of reducing the symptoms of major depression, we plan to assess anxiety, cognition, sexual function, sleep, validated depression biomarkers and onset of action to further define the product profile of MIN-117 as an agent that can potentially address these shortcomings.”
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The study population will consist of adults with a diagnosis of moderate or severe MDD with anxious distress and without psychotic features. Based upon previous clinical observations, the Company believes that patients with MDD who also have symptoms of anxiety may benefit from treatment with MIN-117.
Approximately 324 patients are expected to be enrolled at approximately 40 sites in the U.S. and Europe. Patients will be randomized to one of three arms, including placebo and the two dosage arms, in a 2:1:1 ratio, resulting in approximately 162 patients in the placebo group and 81 patients in each of the two MIN-117 treatment groups. The study design includes a screening phase of up to three weeks, a six-week double-blind treatment phase and a two-week post-study follow-up period. Top line results of the trial are expected in the first half of 2019.