Relmada Therapeutics Strengthens NDV-01 Bladder Cancer Program with Key Leadership Appointments Ahead of Phase 3 Trial
核心洞察
Relmada Therapeutics appointed renowned urologic oncologist Dr. Yair Lotan as Chair of its Clinical Advisory Board to guide NDV-01 development for non-muscle invasive bladder cancer.
The company also named Dr. Raj S. Pruthi as Chief Medical Officer-Urology, bringing over 25 years of experience in urologic oncology and clinical trials.
NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel that showed promising Phase 2 results at AUA 2025, with Phase 3 trials expected to begin in H1 2026.
Relmada Therapeutics has made two strategic leadership appointments to advance its NDV-01 bladder cancer program as the company prepares for Phase 3 trials in the first half of 2026. The clinical-stage biotechnology company appointed Dr. Yair Lotan as Chair of its Clinical Advisory Board and Dr. Raj S. Pruthi as Chief Medical Officer-Urology, both bringing extensive expertise in urologic oncology and bladder cancer treatment.
Expert Leadership for Bladder Cancer Innovation
Dr. Lotan, a distinguished urologic oncologist with over 20 years of experience in bladder cancer care, will chair Relmada's Clinical Advisory Board. His appointment comes as the company builds on positive Phase 2 data for NDV-01 presented at the American Urology Association 2025 Annual Meeting on April 28, 2025.
"We believe that Yair's first-hand understanding of the current treatment challenges in bladder cancer, combined with his deep clinical development expertise, will help to strengthen and enrich the clinical development program for NDV-01," said Sergio Traversa, Chief Executive Officer of Relmada.
Dr. Lotan brings nationally recognized expertise in molecular biomarkers and has been involved in establishing practice guidelines for bladder cancer management. He has published over 650 peer-reviewed papers and serves as an editorial reviewer for major medical journals including the Journal of Urology and European Urology.
Clinical Development Expertise
Dr. Pruthi's appointment as Chief Medical Officer-Urology adds significant clinical development experience to the NDV-01 program. With over 25 years in industry and academic medicine, he previously served as Chief Medical Officer at enGene Holdings (搜索) Inc. and as Global Medical Affairs leader at Johnson and Johnson (搜索) Innovative Medicine.
"Advancing innovative, bladder-sparing treatments for bladder cancer has been the focus of my career. I joined Relmada because I believe NDV-01 has unique potential to become a class-leading therapy for the treatment of NMIBC," commented Dr. Pruthi.
Dr. Pruthi has contributed to developing American Urological Association practice guidelines for NMIBC and brings extensive experience in designing and executing global clinical studies for bladder cancer treatments.
NDV-01's Therapeutic Potential
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel designed to enable bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity.
"In my view, impressive initial Phase 2 data presented at AUA 2025 solidly support NDV-01's unique potential to become a class-leading, bladder-sparing therapy for the treatment of NMIBC," commented Dr. Lotan. "While the combination of gemcitabine/docetaxel has been embraced by the medical community, it is difficult to formulate the combination outside of a hospital setting."
The treatment is designed for in-office administration in less than 10 minutes without requiring anesthesia or specialized equipment, potentially enabling wider patient adoption compared to current complex formulations.
Addressing Significant Unmet Need
Non-muscle invasive bladder cancer represents approximately 75% of all bladder cancer cases and is associated with high recurrence rates of 50-75% over 7 years. With over 600,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant.
"Current treatments are complex to administer and burdensome for patients. Promising Phase 2 data presented at AUA 2025 showed that NDV-01's gemcitabine/docetaxel sustained release formulation produced impressive response rates, with favorable overall tolerability, in a simple ready-to-use administration," noted Dr. Pruthi.
NDV-01 has the potential to serve as both frontline and salvage therapy and could be applicable across multiple NMIBC subtypes. The drug candidate is protected by patents through 2038, providing substantial intellectual property protection for the program's commercial potential.