Relmada Provides Enrollment Update in REL-1017 Study

Relmada Therapeutics announces that since dosing the first subject on June 27, 2017, 25% of the planned subjects received treatment in its Phase 2 study of dextromethadone (REL-1017) in depression. None of the treated subjects experienced either serious adverse events or psychotomimetic adverse events. Overall REL-1017 continues to show an acceptable safety and tolerability profile, which confirms what was previously observed in the Phase 1 single ascending dose and multiple ascending dose studies. The Phase 2 study is expected to be completed and top line results released in the first half of 2019.

"We are very pleased by the higher than expected enrollment rate that we have observed so far and by the emerging safety and tolerability data" said Dr. Ottavio Vitolo, CMO and Head of R&D of Relmada Therapeutics. "Based on this positive initial enrollment, we continue to expect top-line data from this trial in the first half of 2019.  The recent New Drug Application submission for esketamine nasal spray, a potential first-in-class NMDA antagonist and rapidly acting antidepressant, is an important achievement for this new class of antidepressant drugs.  We believe that dextromethadone has the potential to be best-in-class as a once-a-day oral tablet without ketamine-like psychotomimetic side effects."

The Phase 2, multicenter, randomized, double-blind, placebo-controlled, 3-arm study is designed to assess the safety, tolerability, and antidepressant effect of REL-1017 at two doses (25 mg QD and 50 mg QD) as an adjunctive therapy in the treatment of patients diagnosed with major depressive disorders.  Participating subjects are adults with major depressive disorder (MDD) who have experienced an inadequate response to 1 to 3 adequate courses of treatment with an antidepressant medication during the current episode.  The study will enroll 60 subjects at approximately 10 sites in the United States.

REL-1017 (dextromethadone) is an orally administered NMDA receptor (NMDAR) antagonist, which is active on the NMDAR ketamine binding site and has demonstrated an overall favorable safety profile without ketamine psychotomimetic adverse reactions in two Phase 1 studies. In preclinical studies, REL-1017 showed antidepressant efficacy and effects on neuronal activity similar to that of ketamine. The U.S. Food and Drug Administration previously granted Fast Track designation for dextromethadone for the adjunctive treatment of MDD.

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