Phase 3 Study Supports Efficacy, Safety of New Chemical Entity for MDD

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Results from a long-term phase 3 study supported the efficacy and safety of a new chemical entity (NCE) for the treatment of major depressive disorder (MDD).

The study—a long-term, open-label, registrational, non-comparative trial known as Study 310—evaluated the safety and efficacy of REL-1017 administered once-daily in patients with MDD over a period of up to 1 year. In it, the investigators found that patients experienced fast, clinically meaningful, and sustained improvements in symptoms of depression and related functional impairment. They also found that REL-1017 was well-tolerated over the course of long-term dosing; noted low rates of adverse events and adverse event-related discontinuations; and detected no additional safety signals.¹

A total of 627 patients participated in Study 310, 423 of whom had transitioned from Study 301, Study 302, or Study 303 (all previous placebo-controlled trials involving REL-1017) and 204 of whom had not previously taken part in any REL-1017 trials. The Study 310 trial concluded after a minimum of 300 patients had received REL-1017 treatment for a period of 6 months and roughly 100 patients had received the treatment for a period of 12 months. At the conclusion of Study 310, 418 participants had completed at least 6 months of treatment and 118 participants had completed at least 12 months of treatment.¹

The results showed that, in the de novo participants, there was fast and substantial improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) mean total score over time, which moved from 33.8 points at baseline to 22.5 points at month 12. There were high rates of fast and sustained clinical response, wherein 26.6% of de novo participants achieved 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. There were also meaningful rates of clinical remission, which 12.1% of de novo participants had achieved by day 7, 30.1% by month 1, 44.0% by month 3, 47.8% by month 6, and 54.4% by month 12. The study investigators also identified significant reductions in MDD-associated anxiety and functional impairment, as well as evidence of long-term tolerability and safety, with discontinuations due to adverse events occurring in only 3% of participants.¹

“These efficacy and safety results represent real-world potential outcomes for MDD patients when treated with REL-1017,” said Cedric O’Gorman, MD, chief medical officer for Relmada Therapeutics (developer of REL-1017), in a news release. “The rapid and sustained therapeutic effects achieved with REL-1017 suggest the significant therapeutic potential of this promising late-stage product candidate as a mechanistically novel and differentiated treatment for MDD. The early magnitude and trajectory of clinical improvement remain consistent across all trials conducted to date. The long-term sustained clinical improvement, coupled with an extremely well-tolerated profile, adds to our enthusiasm for this agent as a potential therapeutic option for patients and prescribers.”

REL-1017 is an NCE and novel NMDA receptor channel blocker that targets hyperactive channels while also continuing physiological glutamatergic neurotransmission that is currently in the late stages of development as a fast-acting, oral, once-daily antidepressant for the adjunctive treatment of MDD. In addition to the aforementioned long-term, open-label study, REL-1017 is also being evaluated in the Relight (study 304) and Reliance II (Study 302) trials, both of which have the same essential parameters within their study design.¹

Reference

1. Relmada Therapeutics announces efficacy and safety results from phase 3 long-term study of REL-1017 in major depressive disorder. Cision PR Newswire. News release. September 20, 2023. Accessed September 20, 2023. https://www.prnewswire.com/news-releases/relmada-therapeutics-announces-efficacy-and-safety-results-from-the-phase-3-long-term-study-of-rel-1017-in-major-depressive-disorder-301933333.html