Relmada Therapeutics (NASDAQ: RLMD) Reports Interim Analysis Results for Reliance II Phase 3 Study

On December 4, 2024, Relmada Therapeutics, Inc. (NASDAQ: RLMD) issued a press release following a pre-planned interim analysis of the Reliance II Phase 3 study. The analysis, conducted by an independent Data Monitoring Committee, indicated that the study is futile and is unlikely to meet the primary efficacy endpoint with statistical significance.

The Reliance II study is focused on evaluating REL-1017 as an adjunctive treatment for major depressive disorder (MDD), to be used alongside other approved anti-depressants. Despite the outcome of the interim analysis, no new safety concerns were identified during the review.

Regarding the results, Sergio Traversa, Chief Executive Officer of Relmada, expressed disappointment and mentioned that the company will thoroughly assess the full dataset to determine the next steps for the REL-1017 program. Despite this setback, Relmada remains dedicated to advancing the Phase 1 study of REL-P11, an investigational agent designed for the treatment of metabolic diseases.

REL-1017, the focus of the now-futile Reliance II study, is a new chemical entity and a novel NMDA receptor channel blocker designed to target hyperactive channels while maintaining physiological glutamatergic neurotransmission. On the other hand, REL-P11, now at the forefront of Relmada’s commitments, aims to address metabolic diseases by leveraging the potential of psilocybin and its derivatives.

As of September 30, 2024, Relmada boasted a healthy financial position, with approximately $54.1 million in cash and cash equivalents. The company remains motivated to make a difference in the lives of patients and their families by focusing on diseases of the central nervous system (CNS) and metabolic disorders.

During these adverse outcomes, Relmada assures proactive measures in assessing the REL-1017 program while holding steadfast in the development of REL-P11 for metabolic disease. Despite challenges faced, the company remains transparent about its commitment towards patient welfare and advancement in the healthcare sector.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Relmada Therapeutics’s 8K filing here.

Relmada Therapeutics Company Profile

Relmada Therapeutics, Inc, a clinical-stage biotechnology company, focuses on developing various products for the treatment of central nervous system diseases (CNS) and other disorders in the United States. Its lead product candidate is Esmethadone (d-methadone, dextromethadone, and REL-1017), a N-methyl-D-aspartate receptor antagonist which is in phase 3 clinical trial for the adjunctive or monotherapy treatment of major depressive disorder.