Relmada Therapeutics reports Q3 EPS (73c) , consensus (91c)

“We continue to advance our Phase 3 clinical development plan for REL-1017 as an adjunctive treatment for major depressive disorder” said CEO Sergio Traversa. “Enrollment in the ongoing Reliance II (study 302) is progressing as planned and it remains on track to be completed in the in the first half of 2024. The initial patients have been enrolled into Relight, the new Phase 3 study (study 304), and we continue to anticipate the completion of this trial in the second half of next year. Additionally, we are encouraged by the recently announced efficacy and safety data from the one year, open-label safety study, Reliance-OLS (study 310), which showed rapid and sustained improvement in MADRS score with REL-1017 in both de novo patients and the full analysis set. We also recently presented new compelling preclinical data demonstrating the beneficial effect of non-psychedelic/low dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver disease. Based on these promising results, we intend to commence a single-ascending dose Phase 1 trial in obese patients with steatotic liver disease in early 2024 to define the pharmacokinetic, safety, and tolerability profile of our modified-release psilocybin formulation in this population, followed by a Phase 2a trial in the same patient population to establish clinical proof-of-concept. Importantly, there are currently no approved drugs for MASLD, and these initial pre-clinical data support the therapeutic potential of non-psychedelic/low dose psilocybin.”