Screens first patient in Phase 2b trial of MIN-117 to treat Major Depressive Disorder; Multi-center trial to enroll approximately 324 patients at approximately 40 clinical sites in U.S. and Europe
- 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."