Relmada Therapeutics has completed dosing of 25% of the planned subjects in its Phase ll clinical trial of dextromethadone (REL-1017) to treat patients with major depressive disorder.
The dosing for the trial commenced in June last year and has not caused any of the patients treated with REL-1017 to experience serious adverse events or psychotomimetic adverse events.
REL-1017 has also continued to demonstrate an acceptable safety and tolerability profile, thereby validating the previously observed data from the Phase l single-ascending dose and several ascending-dose studies.
The trial is expected to be closed and publish top-line results in the first half of next year.
Relmada Therapeutics CMO and R&D head Dr Ottavio Vitolo said: “We are very pleased by the higher than expected enrolment rate that we have observed so far and by the emerging safety and tolerability data.
“Based on this positive initial enrolment, 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.”
The Phase ll trial is a multicentre, randomised, double-blind, placebo-controlled, three-arm study that aims to evaluate the safety, tolerability, and antidepressant effect of REL-1017 at two daily doses, including 25mg and 50mg.
It has been enrolling adult subjects with MDD who have had an inadequate response to one to three adequate courses of treatment during the current episode.
The trial is expected to enrol 60 subjects at around ten sites in the US.