Relmada Therapeutics announced the last subject has completed dosing with REL-1017 (dextromethadone) in the company's double-blind, placebo-controlled Phase 2 clinical study evaluating the safety and efficacy of REL-1017 as an adjunctive treatment in patients affected by treatment-resistant depression. The company expects to announce topline results from the study in Q3 2019.
"We are very excited to have achieved this important milestone in the clinical development of REL-1017 for major depressive disorder," said Dr. Ottavio Vitolo, Relmada Head of R&D and CMO. "A total of 62 subjects were randomized and received treatment with REL-1017. None of the subjects experienced either serious adverse events or psychotomimetic adverse events, and no subject discontinued treatment because of safety or tolerability issues. Thus far, the blinded data confirms the favorable safety and tolerability profile of REL-1017 previously observed in the Phase 1 studies. We look forward to presenting top line data from this study by the end of Q3 2019."
REL-1017 is an orally administered NMDA receptor (NMDAR) antagonist shown to be active on the NMDAR ketamine binding site. Two Phase 1 studies previously demonstrated an overall favorable safety profile with no psychotomimetic adverse reactions, which are commonly associated with ketamine treatment. In preclinical studies, RLMD-1017 showed antidepressant efficacy and effects on neuronal activity similar to that of ketamine. REL-1017 has the potential to be the first orally available fast acting agent for the treatment of major depressive disorder for patients with depression not responding to standard antidepressant therapies.
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"The completion of dosing of the last subject in our landmark Phase 2 study highlights the significant progress we are making at Relmada in our effort to bring a new treatment option to patients around the world who suffer from depression," said Sergio Traversa, CEO of Relmada. "This study will provide important information on the antidepressant activity of REL-1017, which will enable Relmada to critically advance its clinical development."
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled 3-arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). Subjects in the study are adults with MDD who have experienced an inadequate response to one to three courses of treatment with an antidepressant medication. The study enrolled 62 subjects at approximately 10 sites in the United States. Relmada expects to report top line data from this study before the end of Q3 2019.
REL 1017 (dextromethadone) is an NMDA receptor antagonist targeting the same binding site as ketamine. Thus far, REL 1017 appears to be devoid of the psychotomimetic side effects associated with ketamine treatment and is fundamentally differentiated from all currently FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat depression. In April 2017, the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder. The availability of a daily oral therapy that demonstrates efficacy more rapidly and offers an advantageous safety profile would represent a major advance in patient care in the treatment of depression.