Relmada Therapeutics Announces Positive Progress in MDD and Metabolic Disease Programs
Key Insights
Relmada Therapeutics anticipates an interim analysis of its Phase 3 Reliance II trial for REL-1017 in major depressive disorder (search) by the end of 2024, marking a potential de-risking event.
A Phase 1 study for REL-P11, targeting metabolic disease (search), is expected to commence by the end of 2024, following promising preclinical results.
The company's cash position of $54.1 million is projected to sustain operations through key milestones into 2025, supporting ongoing clinical development.
Relmada Therapeutics is advancing its clinical programs for central nervous system disorders and metabolic diseases. The company's lead candidate, REL-1017, is currently in Phase 3 development as an adjunctive treatment for major depressive disorder (search) (MDD). Two ongoing trials, Reliance II and Relight, are designed to build upon positive Phase 2 results, incorporating enhanced site selection and stringent patient enrollment criteria.
Reliance II Interim Analysis
The Reliance II study includes a pre-planned interim analysis to evaluate futility and sample size. Relmada anticipates the outcome of this analysis by the end of 2024. According to Sergio Traversa, CEO of Relmada, this outcome represents a potentially significant de-risking event for the REL-1017 program and the company.
The Phase 3 program for REL-1017 includes two randomized, double-blind, placebo-controlled studies, Reliance II (Study 302) and Relight (Study 304). The primary endpoint for both studies is the change in the Montgomery-Asberg Depression Rating Scale (MADRS) at Day 28.
REL-P11 for Metabolic Disease
Relmada also plans to initiate a Phase 1 safety study for REL-P11 for metabolic disease (search) by the end of 2024. This low-dose, modified-release psilocybin formulation has demonstrated improved metabolic parameters in preclinical models. The Phase 1 study, to be conducted in Canada, will assess the pharmacokinetic, safety, and tolerability profile of REL-P11 in obese subjects. A Phase 2a proof-of-concept study is expected to begin in the first half of 2025.
Financial Update
Relmada's financial results for the third quarter of 2024 show a research and development expense of $11.1 million, compared to $10.4 million for the same period in 2023. General and administrative expenses totaled $11.9 million, a decrease from $12.2 million in the prior year. The net loss for the quarter was $21.7 million, or $0.72 per share.
As of September 30, 2024, Relmada had cash, cash equivalents, and short-term investments of approximately $54.1 million. The company believes this cash balance is sufficient to support planned operations through key near-term milestones into 2025.