Relmada Therapeutics Launches New Phase 1 Trial Of Metabolic Disease Therapy

Relmada Therapeutics, Inc., a biotechnology firm focused on advancing treatments for central nervous system (CNS) disorders, has announced the beginning of dosing in a Phase 1 single-ascending dose (SAD) study of REL-P11. This investigational therapy is being explored as a potential treatment for metabolic diseases.

Sergio Traversa, Chief Executive Officer of Relmada, said in a statement, “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 (AASLD 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.”

He also commented, “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.”