Relmada Therapeutics Presents Promising 6-Month Data for NDV-01 Bladder Cancer Treatment at Urologic Oncology Meeting
核心洞察
Relmada Therapeutics presented 6-month follow-up data from its ongoing Phase 2 trial of NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer.
The company reported a 92% complete response rate at any time point from 9-month data and plans to advance NDV-01 into Phase 3 studies in two indications by the first half of 2026.
NDV-01 targets high-risk and intermediate-risk NMIBC, representing approximately 80% of new cases annually or about 54,000 patients in the United States.
Relmada Therapeutics presented encouraging 6-month follow-up data from its ongoing Phase 2 study of NDV-01 at the Society of Urologic Oncology 26th Annual Meeting, marking a significant milestone for the company's bladder cancer treatment program. The sustained-release intravesical formulation of gemcitabine and docetaxel demonstrated favorable overall safety in patients with non-muscle invasive bladder cancer (NMIBC).
Strong Efficacy Results Drive Phase 3 Plans
The clinical data supporting NDV-01's advancement includes a remarkable 92% complete response rate at any time point from recently announced 9-month data. This efficacy profile, combined with encouraging FDA discussions, has positioned Relmada to initiate Phase 3 studies in two distinct NMIBC indications during the first half of 2026.
"We believe NDV-01 has the opportunity to transform the treatment of NMIBC by providing patients and physicians with a potential bladder-sparing, in-office, ready-to-use, safe, effective and durable, best-in-class therapy," stated Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics.
Addressing Significant Market Need
The company is strategically focusing on high-risk and intermediate-risk NMIBC, which represents approximately 80% of new NMIBC cases annually, translating to about 54,000 patients in the United States. NMIBC accounts for 75-80% of all bladder cancer cases and carries a high recurrence rate of 50-80% over five years, with over 744,000 prevalent cases in the U.S. and limited treatment options currently available.
Innovative Drug Delivery System
NDV-01's unique formulation is designed to enable gemcitabine and docetaxel bladder retention with gradual drug release over 10 days. The treatment creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The ready-to-use formulation can be conveniently administered in-office in less than 10 minutes without requiring anesthesia or specialized equipment.
Comprehensive Phase 2 Study Design
The ongoing Phase 2 study (NCT06663137) is an open-label, single-arm, single-center trial evaluating NDV-01's safety and efficacy in patients with high-grade NMIBC. The treatment protocol includes a biweekly induction phase followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy as indicated.
The study's primary efficacy endpoints focus on safety and complete response rate at 12 months, while secondary endpoints include duration of response and event-free survival. This comprehensive approach provides multiple measures of treatment success and durability.
Broad Therapeutic Potential
NDV-01 has the potential to serve as both a frontline and salvage therapy, with applicability across multiple NMIBC subtypes. The treatment is protected by patents through 2038, providing substantial intellectual property coverage for the company's development and commercialization efforts.
The poster presentation, delivered by Yair Lotan, MD, Chairman of Relmada's Clinical Advisory Board, highlighted the 6-month complete response data and overall safety profile that supports the company's advancement toward Phase 3 development.