Relmada Therapeutics, Inc. Announces Publication of Rel-1017 Phase 2 Study Results in the American Journal of Psychiatry
December 22, 2021 at 09:02 am
Share
Relmada Therapeutics, Inc. 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 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 MontgomeryAsberg Depression Scale (MADRS) score. The trial was conducted at ten centers in the United States from May 2018 to August 2019. 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.
Relmada Therapeutics, Inc. is a clinical-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). The Company is focused on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone, an isomer of methadone, is a new chemical entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders. The Companyâs lead program, REL-1017, is a NCE and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Its esmethadone, is being developed as a rapidly acting, oral agent for the treatment of depression and other potential indications.