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.

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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.”