Nanjing-based Minova Pharmaceuticals Co., Ltd. has announced positive results from a Phase 2 clinical trial of its Category 1 drug, MI078 capsules, for the treatment of postpartum depression. The trial demonstrated MI078’s effectiveness in short-term symptom control, long-term efficacy maintenance, and safety, with significant improvements observed after just three days of administration.
Clinical Trial Results
The study achieved its primary endpoint, showing a clear reduction in HAMD-17 scores from baseline on Day 4. MI078 exhibited a dose-response relationship, with the high-dose group demonstrating a significantly greater reduction in HAMD-17 scores compared to the placebo group (difference: -6.0 ± 1.78, p = 0.0013). Long-term observations revealed sustained therapeutic effects over 28 days post-treatment.
Safety Profile
MI078 capsules showed a favorable safety profile, with adverse events comparable across all dosage groups and the placebo group. Most adverse reactions were mild to moderate, primarily involving gastrointestinal discomfort, and no serious adverse events were reported.-Fineline Info & Tech
