Relmada Therapeutics (NASDAQ:), Inc. (Nasdaq: RLMD) today provided a corporate update, highlighted the Company's key 2023 accomplishments and outlined its anticipated 2024 clinical development milestones.
"We made significant operational progress throughout our business in 2023 and believe we are well-positioned for making 2024 the pivotal and most important year for Relmada to date," said Sergio Traversa, Relmada's Chief Executive Officer. "In our ongoing Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder (MDD), we completed a thorough analysis of the study 301 and study 303 results, and subsequently made important revisions to our clinical development plan, including optimizing the study protocols, improving the patient adjudication process, enhancing the site engagement strategy, and reorganizing our clinical team to better align with the ongoing study 302 and study 304 clinical study operations requirements. 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."
"In addition, we advanced our valuable non-psychedelic/low dose metabolic psilocybin program, which showed significant therapeutic potential on multiple parameters in pre-clinical rodent studies," continued Mr. Traversa. "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."
We would like to thank our outgoing Chief Medical Officer, Dr. Cedric O'Gorman, for his contribution in the optimization of the clinical development strategy for the REL 1017 studies 302 and 304. We also welcome Dr. Andrew Cutler as Senior Clinical Development Advisor, who will help Relmada through the completion of the REL-1017 Phase 3 program and the NDA/approval process.
Upcoming Anticipated Milestones
- Complete enrollment in REL-1017 study 302 (Reliance II), which is planned to enroll approximately 300 patients, in the first half of 2024.
- Complete enrollment in REL 1017 study 304 (Relight), which is planned to enroll approximately 300 patients, by year-end 2024.
- Commence a 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 (REL-P11), followed by a Phase 2a trial to establish clinical proof-of-concept with data expected in the first half of 2025.
