Relmada Therapeutics Announced Publication of Results from the Phase 3 Reliance I Study of REL-1017 in The Journal of Clinical Psychiatry
Relmada Therapeutics announced the publication of Phase 3 clinical data for REL-1017 (esmethadone) from the Reliance I Study in The Journal of Clinical Psychiatry. The study focused on patients with Major Depressive Disorder (MDD) who had an inadequate response to standard antidepressants. The results confirmed the efficacy, safety, and tolerability of esmethadone, aligning with previous Phase 2 findings. The side-effect profile was favorable compared to current FDA-approved treatments for MDD, highlighting esmethadone's potential as an adjunctive therapy.
- Publication of Phase 3 study results in a peer-reviewed journal enhances credibility.
- Positive efficacy, safety, and tolerability data for REL-1017.
- Favorable side-effect profile compared to existing FDA-approved treatments.
- Potential for REL-1017 to be a promising adjunctive therapy for MDD.
- The announcement does not include any new financial or business development updates.
- No details provided on market approval timelines or next steps for REL-1017.
- Potential over-reliance on previous Phase 2 results without significant new insights.
Insights
REL-1017, also known as esmethadone, has shown promising results in the Phase 3 Reliance I Study, targeting patients with major depressive disorder (MDD) who have not responded adequately to standard antidepressants. This publication in a peer-reviewed journal underscores its potential efficacy and safety, which is significant for both the medical community and investors.
One of the key aspects here is the clinical validation provided by this Phase 3 trial. A positive outcome in such a late-stage study suggests that esmethadone could be a viable option for a subset of MDD patients who are currently underserved by existing treatments. The favorable side-effect profile also sets it apart, potentially offering a safer alternative to current adjunctive therapies approved by the FDA. This is important because side effects often limit the use of antidepressants, affecting patient adherence and overall treatment success.
From a regulatory standpoint, the consistency between the Phase 2 and Phase 3 results enhances the likelihood of FDA approval, which could lead to significant market potential. MDD is a substantial market with a high unmet need and a new entrant with proven efficacy and safety could capture a significant share. However, investors should remain cautious about the next steps, including any additional regulatory hurdles and the competitive landscape which includes several well-established treatments.
The publication of Phase 3 trial results in a reputable journal like The Journal of Clinical Psychiatry is a strong signal for market stakeholders. It tends to boost investor confidence as it indicates robust, peer-reviewed scientific backing. For Relmada Therapeutics, this milestone not only enhances its credibility but also places it in a favorable position for potential partnerships or acquisitions, which are common in the biotech sector, especially when promising treatments are involved.
Relmada's focus on the CNS market is strategic, given the high prevalence and chronic nature of conditions within this space. MDD, in particular, affects millions globally, presenting a lucrative market opportunity. A new, effective adjunctive treatment could address a major gap, potentially translating to substantial revenue streams once the drug is approved and launched.
However, there are market risks to consider. Even with positive clinical trial results, the actual market penetration will depend on factors like pricing strategy, competition from existing and upcoming antidepressants and the ability to gain and maintain insurance coverage. Additionally, the broader economic environment and healthcare budget constraints can impact market adoption rates.
"The overall results from this trial are clearly consistent with the evidence, produced by the prior phase 2 trial, for the efficacy, safety, and tolerability of esmethadone as a promising antidepressant for the adjunctive treatment of major depressive disorder. The side-effect profile of esmethadone compares quite favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD.," said Maurizio Fava, MD, the Principal Investigator of Reliance I.
About Reliance I
Reliance I was a 28-day, Phase 3, randomized, double-blind, placebo-controlled study to evaluate REL-1017 (75 mg on day 1, followed by 25 mg daily on days 2 through 28) compared to placebo as adjunctive treatment in patients with major depressive disorder (MDD). The intent-to-treat (ITT) population comprised 227 randomized patients; the per protocol (PP) population comprised 198 patients completing treatment. The primary efficacy measure was mean difference (MD) between REL-1017 and placebo in change from baseline (CFB) through day 28 in the Montgomery-Asberg Depression Rating Scale (MADRS) score.
As reported in December 2022, Reliance I did not meet the primary endpoint in the ITT analysis, yet, REL-1017 showed a statistically significant improvement in response rate compared to placebo (P = .044) and an encouraging nonsignificant trend for improvement in remission rate (P = .076). In the PP prespecified supportive analysis that excluded protocol noncompliant patients for reasons unrelated to REL-1017 adverse events (AE), results trended toward a more favorable outcome (MD CFB = 3.1; P =.051, ES = 0.29). Further, in post hoc analyses of patients with severe depression (MADRS score ≥35 at baseline), significant improvement as measured occurred with REL-1017 vs. placebo in both the ITT and PP populations (MD CFB 6.9 and 7.9; P =.0059 and P = .0015; ES = 0.57 and 0.68, respectively)
The side effect profile of REL-1017 was consistent with previous phase 1 and phase 2 studies of REL-1017, with no observations of treatment-related serious AEs and no observed signal for abuse potential and compares favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD.
About REL-1017
REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the adjunctive treatment of major depressive disorder (MDD). Relmada's ongoing clinical research program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. The development program for REL-1017 as an adjunctive treatment for MDD includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302) and Relight (Study 304). Reliance II and Relight have the same key study design parameters.
Relmada continues to enroll patients in both ongoing REL-1017 trials including Reliance II (Study 302), with top-line data anticipated in the second half of 2024, and Relight (Study 304) with top-line data anticipated approximately six months after the completion of Study 302.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada's experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada's lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Learn more at www.relmada.com.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential failure of clinical trial results to demonstrate statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of the 310 open-label study to accurately reflect the results of the ongoing 302 and 304 blinded, randomized and controlled studies, failure of the planned psilocybin Phase 1 and Phase 2a trials to be successfully carried out, failure to obtain regulatory approval of REL-1017 for the treatment of major depressive disorder, and the other risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
Tim@LifeSciAdvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
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