Relmada Therapeutics has announced that the Phase 3 Reliance II trial of REL-1017, an adjunctive treatment for major depressive disorder (MDD), is unlikely to meet its primary efficacy endpoint based on an interim analysis conducted by the Independent Data Monitoring Committee (DMC). The DMC's assessment indicated futility, leading Relmada to re-evaluate the future of the REL-1017 program. The company's stock value plummeted following the announcement.
Trial Details and Findings
The Reliance II trial was designed to evaluate REL-1017 in combination with other approved antidepressants for the treatment of MDD. The pre-planned interim analysis by the DMC revealed that the trial was unlikely to achieve statistical significance in its primary efficacy endpoint. While the DMC did not identify any new safety concerns, the futility finding necessitates a reassessment of the program's direction.
Sergio Traversa, Chief Executive Officer of Relmada, expressed disappointment with the outcome, stating, "Based on these results, Relmada will evaluate the full dataset to determine next steps for the REL-1017 program." He also acknowledged the contributions of the investigative sites and patients who participated in the trial.
Future Plans for Relmada
Despite the setback with REL-1017, Relmada remains committed to the development of REL-P11, an investigational agent for the treatment of metabolic disease. REL-P11 is currently in a Phase 1 first-in-human study. The company reported a solid financial position with approximately $54.1 million in cash and cash equivalents as of September 30, 2024, ensuring continued support for its ongoing research programs.
About REL-1017 and REL-P11
REL-1017 is a novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-P11 is a low-dose, modified-release formulation of psilocybin being developed for metabolic diseases, leveraging psilocybin's neuroplastogen™ effects.
Analyst Commentary
Mizuho analyst Uy Ear commented on the news, stating the futility finding is truly disappointing & likely means end for REL-1017 in MDD. RLMD likely to trade down sharply."
