Relmada Therapeutics has dosed the first patient in a Phase ll clinical trial of REL-1017 (dextromethadone) for the treatment of patients diagnosed with major depressive disorder (MDD) that did not respond to currently available antidepressants.
The multicentre, randomised, double-blind, placebo-controlled, three-arm trial is designed to investigate the safety, tolerability and efficacy of 25mg and 50mg oral doses of REL-1017 as adjunctive therapy for MDD.
The trial intends to enrol 60 adult MDD patients who have experienced an inadequate response to one to three adequate courses of treatment with an antidepressant medication during the current episode.
It will be conducted at around ten sites in the US. The study expects to release a top line report in the first half of next year.
Relmada Therapeutics R&D head and CMO Dr Ottavio Vitolo said: “REL-1017 is an orally administered NMDA receptor (NMDAR) antagonist, which is active on the NMDAR ketamine binding site and has demonstrated an overall favourable safety profile without ketamine psychotomimetic adverse reactions in two Phase l studies.
“In preclinical studies, REL-1017 showed antidepressant efficacy and effects on neuronal activity similar to that of ketamine.
“REL-1017 has the potential of becoming the first orally available fast-acting agent for the treatment of major depressive disorder and to improve the lives of individuals with depression not responding to standard antidepressant therapies.”
Relmada is currently engaged in developing dextromethadone as a rapidly acting oral agent for the treatment of depression.
In April last year, dextromethadone received fast-track designation from the US Food and Drug Administration (FDA) to be used as adjunctive treatment of MDD.