Relmada Therapeutics initiates Phase 1 dosing with REL-P11

Relmada Therapeutics (RLMD) announced the initiation of dosing in a Phase 1 SAD study of REL-P11, an investigational agent for metabolic disease. “Dosing of the first subjects in the Phase 1 study is an important milestone for REL-P11, a low-dose, modified-release psilocybin formulation. Preclinical rodent studies, published at the American Association for the Study of Liver Disease in 2023, showed that treatment with REL-P11 improved multiple metabolic parameters with no detrimental CNS effects, and suggest that REL-P11 could have potential to become a valuable therapeutic option in the evolving obesity and metabolic syndrome space,” said Sergio Traversa, Chief Executive Officer of Relmada. “We expect the Phase 1 study to help define the pharmacokinetic, safety and tolerability profile of REL-P11 and, with positive data, pave the way for a Phase 2a proof-of-concept study to begin in H1 2025.”