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2022-12-07| Trials & Approvals

Relmada Blames ‘Implausible Placebo Results’ on Depression Drug’s Failure Again

by Reed Slater
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Just months after posting Phase 3 trial results for its major depressive disorder (MDD) drug’s poor performance in the clinic as a monotherapy, Relmada is back at the press table discussing REL-1017’s less-than-stellar results as an adjunctive therapy. As before, the company put most of the blame on two high-enrolling study centers where data showed “implausible results” and the placebo rapidly outperformed REL-1017.

Fishing for Possible Answers to Surprising Data

Relmada’s RELIANCE I study enrolled 232 participants with previously diagnosed depression who had not responded to at least one and up to three antidepressant therapies. Throughout the trial, random participants received a 25 mg oral REL-1017 tablet daily alongside existing antidepressant therapies. 

Including all of the study centers, REL-1017 patients experienced a Montgomery-Asberg Depression Rating Scale (MADRS) reduction of 15.1 points compared to a 12.9-point decrease in the placebo population. Without the selected study centers, Relmada said the REL-1017 patients experienced a 16.7-point reduction in the MADRS compared to a 12.6-point decrease in the placebo arm. Excluding certain study centers would have nearly doubled the overall MADRS point reduction in favor of REL-1017 throughout the study.

Based on the results that Relmada appears to find dubious, the company said it is changing its trial protocol in proceeding clinical trials to adjust for the high placebo performance in specific study centers. Despite the poor performance in the RELIANCE I and III studies, Relmada is forging ahead in the RELIANCE II study, which will also study REL-1017’s efficacy as an adjunctive MDD therapy. 

Related Article: Otsuka and Lundbeck’s Treatment for Schizophrenia and Bipolar I NDA Accepted by the FDA

REL-1017 and Relmada Going Forward

Because REL-1017 is Relmada’s only drug in clinical-stage development right now, the recent Phase 3 study results are a massive blow to the company. The RELIANCE III results published in October resulted in a sharp drop in the company’s stock, and the RELIANCE I results are not doing the company any favors either. 

Relmada still has a chance to climb out of its current hole, with two other clinical trials in the works. The RELIANCE II trial is in Phase 3 trials. The company is also working on the RELIANCE-OLS trial, which will include rollover patients from the previous trials to study REL-1017’s long-term safety and efficacy. Relmada also recently acquired the rights to some psilocybin and derivative compounds; however, the company has not yet published any updates on the development program’s status. 

In light of the recent Phase 3 trial results, Relmada has some pieces to pick up while it moves forward in REL-1017’s development. There is still a huge market for MDD therapies, and based on REL-1017’s safety profile, the company still seems optimistic about the drug and its potential. With RELIANCE II data coming, it will be exciting to see if the drug makes a drastic turnaround or if the results go the same way as the previous two studies. 

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