Relmada Therapeutics Inc (NASDAQ:RLMD) announced efficacy results for the de novo (or new to treatment) patients (204 patients) and safety results for all subjects (627 patients) from the Phase 3 trial (Study 310) of REL-1017 in patients with Major Depressive Disorder (MDD).
Patients treated daily with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment.
REL-1017 was well-tolerated with long-term dosing, showing low rates of adverse events and discontinuations due to adverse events. No new safety signals were detected.
In de novo patients, the mean MADRS total score was 33.8 at baseline. Treatment with REL-1017 in these patients resulted in mean improvements from baseline in the MADRS total score of 11.3 points at Day 7, 16.8 points at Month 1, 19.9 points at Months 3 and 6, and 22.5 points at Month 12.
The Montgomery–Åsberg Depression Rating Scale (MADRS) measures the severity of depressive episodes.
When treated with REL-1017, 26.6% of de novo patients achieved a clinical response by Day 7, 51.0% by Month 1, 60.7% by Month 3, 63.4% by Month 6, and 77.2% by Month 12.
The virtual absence of depressive symptoms was achieved by 12.1% of de novo patients at Day 7, 30.1% at Month 1, 44.0% at Month 3, 47.8% at Month 6, and 54.4% at Month 12.
The mean baseline score on the Hamilton Anxiety Rating Scale, which measures anxiety symptoms, was 20.6 points, reflecting moderate anxiety.
De novo patients treated with REL-1017 saw a continual decline in anxiety symptoms over time.
Price Action: RLMD shares are up 7.53% at $3.00 on the last check Wednesday.
