REL-1017 is intended for the treatment of major depressive disorder. Credit: Africa Studio / Shutterstock.

Relmada Therapeutics has reported positive safety and efficacy results from the long-term Phase III REL-1017-310 trial evaluating REL-1017 in patients with major depressive disorder (MDD). 

The registrational, non-comparative, open-label study assessed the efficacy and safety of REL-1017 in MDD patients for up to one year.

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Out of the total 627 patients, 423 were enrolled from prior placebo-controlled studies while the remaining are de novo patients who did not participate in trials with REL-1017.

Patients treated daily with REL-1017 for up to one year showed sustained improvements in depressive symptoms and associated functional impairment.

Long-term REL-1017 dosing in patients was found to be well-tolerated with low rates of adverse events and no new safety signals were detected.

De novo patients showed improvement in MADRS total score over time and achieved clinical response by day seven and months one, three, six and 12.

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Virtual absence of depressive symptoms (clinical remission) was also observed in these patients at the same measured durations.

At months six and 12, de novo patients treated with REL-1017 showed a reduction in functional impairment associated with MDD, as measured using the Sheehan Disability Scale.

These patients also showed a continual decline in anxiety symptoms over time, as measured by the Hamilton Anxiety Rating Scale (HAM-A).

Relmada Therapeutics chief medical officer Cedric O’Gorman said: “The rapid and sustained therapeutic effects achieved with REL-1017 suggest the significant therapeutic potential of this promising late-stage product candidate as a mechanistically novel and differentiated treatment for MDD.

“The early magnitude and trajectory of clinical improvement remain consistent across all trials conducted to date.”