Relmada Therapeutics Initiates Phase 1 Dosing with REL-P11 for Metabolic Disease

Core Insights - Relmada Therapeutics has initiated dosing in a Phase 1 Single-Ascending Dosing (SAD) study for REL-P11, a low-dose, modified-release psilocybin formulation aimed at treating metabolic diseases [1][2] - The Phase 1 study is expected to define the pharmacokinetic, safety, and tolerability profile of REL-P11, with a Phase 2a proof-of-concept study anticipated to begin in the first half of 2025 if results are positive [2][3] Company Overview - Relmada Therapeutics is a late-stage biotechnology company focused on diseases of the central nervous system (CNS), particularly major depressive disorder (MDD) [4] - The company’s lead program, REL-1017, is a novel NMDA receptor channel blocker in late-stage development as an adjunctive treatment for MDD in adults [4] Research and Development - Relmada acquired the rights to develop a novel psilocybin and derivatives program in July 2021, identifying low-dose psilocybin as a potential treatment for metabolic diseases [3] - Preclinical studies presented at AASLD 2023 indicated that REL-P11 improved multiple metabolic parameters without adverse CNS effects, suggesting its potential as a therapeutic option in obesity and metabolic syndrome [2][3]