Relmada Therapeutics Stock Plummets Losing 80% Value - Here's Why

On Wednesday, Relmada Therapeutics, Inc. RLMD announced a preplanned interim analysis of the Reliance II Phase 3 study.

Reliance II is designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), to be used in combination with other approved anti-depressants.

The Independent Data Monitoring Committee (DMC) analysis indicated that the Reliance II Phase 3 study is futile and unlikely to meet the primary efficacy endpoint with statistical significance.

No new safety signals were reported.

“We are disappointed with the outcome of this interim analysis,” said Sergio Traversa, Chief Executive Officer of Relmada. “Based on these results, Relmada will evaluate the full dataset to determine next steps for the REL-1017 program. The Company will continue to advance the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, currently in a Phase 1 first-in-human study. We are grateful to the investigative sites and patients who participated in the REL-1017 program.”

In July 2021, Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program. Psilocybin has neuroplastogen effects that have the potential to ameliorate neurodegenerative conditions.

Relmada identified the potential to use low-dose psilocybin to treat metabolic diseases and published the data at the American Society for the Study of Liver Disease.

Last year, Relmada Therapeutics released efficacy results for the de novo (or new to treatment) patients (204 patients) and safety results for all subjects (627 patients) from the Phase 3 trial (Study 310) of REL-1017 in patients with Major Depressive Disorder (MDD).

Patients treated daily with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment. 

In November, Relmada Therapeutics initiated dosing in a Phase 1 SAD study of REL-P11, an investigational agent for metabolic disease. Phase 2a proof-of-concept study is expected to begin in the first half of 2025.

Price Action: RLMD stock is down 75.4% at $0.68 at last check Wednesday.

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