Relmada Therapeutics provided a corporate update and outlined its anticipated 2024 clinical development milestones. CEO Sergio Traversa said, “In our ongoing Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder, we completed a thorough analysis of the study 301 and study 303 results…Importantly, study 302 is now approximately 50% enrolled. We have also completed all of the necessary pre-clinical, manufacturing and Phase 1 studies required for a potential REL-1017 NDA filing, and are currently conducting various pre-commercial readiness activities…Looking ahead, we have multiple clinical development milestones expected in 2024, for both REL-1017 and our non-psychedelic/modified-release psilocybin program, and we expect our cash runway to extend beyond all of these anticipated catalysts.” Upcoming anticipated milestones include: complete enrollment in REL-1017 study 302 in the first half of 2024; complete enrollment in REL 1017 study 304 by year-end 2024; commencing Phase 1 trial in obese patients with steatotic liver disease in the first half of 2024 to define the pharmacokinetic, safety and tolerability profile of the company’s modified-release psilocybin formulation, followed by a Phase 2a trial to establish clinical proof-of-concept with data expected in the first half of 2025.
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