Relmada Therapeutics has reported top-line data from the Phase III RELIANCE I trial of a new NMDA receptor (NMDAR) channel blocker, REL-1017, as an adjunctive treatment for major depressive disorder (MDD).
The RELIANCE I trial was designed to assess REL-1017, used along with a standard antidepressant, for patients who did not respond to at least one and up to three standard antidepressant therapies.
The company stated that the RELIANCE I trial results were affected due to high enrolling sites showing implausible placebo responses, similar to the previously announced data from the RELIANCE III study.
Findings showed that patients treated with REL-1017 demonstrated a Montgomery-Asberg Depression Rating Scale (MADRS) reduction of 15.1 points, compared to a 12.9-point decrease in the placebo population at day 28.
In the study, the REL-1017 treatment arm had a 39.8% response rate, compared to 27.2% in the placebo-group.
Excluding the two high enrolling centres, the REL-1017 patients’ arm showed a 16.7 point reduction in the MADRS, compared to a 12.6 point decrease in the placebo arm at day 28.
The company is currently enrolling participants in RELIANCE II, which is said to be the second ongoing Phase II, placebo-controlled, two-arm, pivotal study that will assess REL-1017 as a potential adjunctive treatment for MDD.
It is making many protocol and operational changes to RELIANCE II, based on the data obtained from RELIANCE I and RELIANCE III trials.
Relmada is also making certain improvements to the trial process.
It noted that the RELIANCE development programme also includes the long-term open-label safety study, RELIANCE-OLS, which is assessing the rollover participants from all three pivotal studies, along with de novo participants.