Relmada Therapeutics, Inc., a late-stage biotechnology company addressing diseases of the central nervous system (CNS), announced the publication of Phase 2 data from the clinical study of REL-1017 as adjunctive treatment for patients with major depressive disorder (MDD) in the peer-reviewed American Journal of Psychiatry, the most widely read psychiatric journal in the world. The article is titled, “REL-1017 (Esmethadone) as Adjunctive Treatment in Patients with Major Depressive Disorder: a Phase 2a Double-Blind Randomized Trial,”
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“These compelling data confirm the favorable safety and tolerability profile of REL-1017 without opioid, dissociative, or psychotomimetic effects” said Paolo L. Manfredi, M.D., Chief Scientific Officer of Relmada.
The objectives of the Phase 2, randomized, double-blind, placebo-controlled clinical study were to evaluate the safety, tolerability, and efficacy of two doses of REL-1017 tablets, 25 mg once a day and 50 mg once a day, when given as an adjunctive treatment for MDD in patients with inadequate response to standard antidepressants. A total of 62 patients were randomized to one of three arms: placebo, REL-1017 25 mg, or REL-1017 50 mg. The primary efficacy endpoint was the Montgomery–Asberg Depression Scale (MADRS) score. The trial was conducted at ten centers in the United States from May 2018 to August 2019.
“We look forward to seeing esmethadone potentially helping millions of depressed patients with inadequate response to antidepressants if these efficacy and safety results are replicated in the ongoing Phase 3 trials” said Maurizio Fava, M.D., Principal Investigator and Chair of the Department of Psychiatry at Massachusetts General Hospital (MGH).
Key Findings:
These results confirmed the favorable safety, tolerability, and pharmacokinetic profile of REL-1017 and demonstrated that both doses of REL-1017 produced rapid, robust, and sustained antidepressant effects when compared to placebo in patients with MDD.
The improvement on MADRS shown on Day 4 in both REL-1017 25mg and 50mg groups was sustained through Day 7 (last dose) and Day 14 (7 days after the last dose) with p ≤ 0.0308 and effect sizes (a measure of quantifying the difference between two groups), from 0.7 to 1.0.
There were no serious adverse events and no patients experienced treatment-emergent adverse events (TEAEs) that resulted in treatment discontinuation. Patients experienced only transient mild or moderate transient adverse events comparable to placebo. Additionally, there were no opioid, dissociative or psychotomimetic symptoms or withdrawal effects upon treatment discontinuation.
“We are pleased to share these important Phase 2 data with the psychiatry community,” said Sergio Traversa, Relmada’s Chief Executive Officer. “Importantly, these Phase 2 findings enabled us to advance REL-1017 into the multiple clinical studies RELIANCE Phase 3 program for REL-1017 in MDD.”