Relmada Therapeutics, Inc. (Nasdaq: RLMD) has completed an exclusive licensing agreement with Trigone Pharma, Ltd. for NDV-01, a novel sustained-release intravesical formulation of gemcitabine and docetaxel (gem/doce) designed to treat Non-Muscle Invasive Bladder Cancer (NMIBC). The announcement comes as the Phase 2 clinical trial for NDV-01 continues, with topline efficacy and safety data expected to be presented at the American Urological Association meeting in Las Vegas, April 26-29, 2025.
NDV-01 is being developed to address a significant unmet need in bladder cancer treatment, targeting a U.S. patient population of approximately 600,000 with NMIBC, with about 62,000 newly diagnosed patients annually.
Novel Drug Delivery System for Enhanced Efficacy
NDV-01 represents a significant advancement in NMIBC treatment through its innovative sustained-release formulation. Unlike conventional intravesical treatments that remain in the bladder for only hours, NDV-01 forms a spherical soft matrix within the bladder that gradually dissolves, releasing the active compounds over a 10-day period.
"What makes NDV-01 particularly promising is its sustained-release formulation, securing prolonged dwell time and extensive treatment exposure to bladder tumors and enhancing anti-cancer effects," explained Dan Touitou, CEO of Trigone Pharma. "This innovative approach has the potential not only to improve treatment effectiveness but also to improve patient compliance by offering a convenient in-office treatment alternative to current hospital-based therapies."
The formulation combines two well-established chemotherapy agents—gemcitabine and docetaxel—which have demonstrated efficacy in NMIBC treatment when used in combination. Clinical studies have shown that this combination delivers "impressive efficacy with a manageable safety profile," according to Dr. Yair Lotan, Professor of Urology and Chief of Urologic Oncology at UT Southwestern Medical Center.
Addressing a Significant Market Need
NMIBC represents approximately 75% of all bladder cancer cases, with high-grade disease accounting for about 50% of these cases. The condition is characterized by a high recurrence rate of 50-75% over seven years, creating an ongoing treatment challenge.
Current treatment options remain limited, with Bacillus Calmette-Guerin (BCG) immunotherapy being the primary approach, despite supply constraints. The high recurrence rates lead to frequent re-treatment and disease progression, highlighting the need for more effective therapies.
"There is a significant unmet need for effective treatments for patients with non-muscle invasive bladder cancer who don't respond to BCG therapy," noted Dr. Lotan. The U.S. NMIBC market is estimated to be a multi-billion dollar opportunity, with global projections indicating significant growth due to increasing bladder cancer incidence.
Strategic Expansion of Relmada's Pipeline
For Relmada Therapeutics, the acquisition of NDV-01 represents a strategic expansion of its development portfolio. Sergio Traversa, CEO of Relmada, expressed enthusiasm about the addition: "We are delighted to add NDV-01 to our pipeline as we believe it represents an exceptional value-creation opportunity for Relmada and our investors."
The company views NDV-01 as complementary to its recently acquired asset, sepranolone, a Phase 2b-ready neurosteroid for compulsion-related disorders including Tourette's Syndrome. Maged Shenouda, CFO of Relmada, stated that the addition of both NDV-01 and sepranolone "achieves our principal objectives of diversifying our pipeline while balancing its risk and upside potential."
Clinical Development and Commercial Potential
NDV-01 is currently being evaluated in a Phase 2, Single-Arm Study (NCT06663137) designed to enroll up to 70 subjects with localized, non-metastatic, high-grade NMIBC. Topline data from the first 20 patients are expected to be presented at the upcoming AUA meeting.
The drug candidate has several potential advantages that could drive commercial success:
- Ready-to-use formulation requiring no preparation
- Rapid administration without anesthesia or specialized equipment
- Potential for both inpatient and outpatient clinic use
- Sustained delivery over 10 days versus hours for conventional treatments
- Reduced frequency of dosing
- Improved patient compliance and outcomes
NDV-01 is protected by several patents related to methods of treatment and formulation with terms extending to 2038.
Terms of the Licensing Agreement
Under the agreement, Relmada will make a $3.5 million upfront payment and issue 3,017,420 shares of common stock, representing 10% of Relmada's outstanding shares, to Trigone Pharma. These shares will be subject to a 12-month lock-up period.
The deal grants Relmada exclusive worldwide rights to NDV-01, excluding Israel, India, and South Africa. Additional terms include:
- Up to $200 million in development, regulatory, and sales milestones pending successful commercialization
- A 3% royalty on any net sales
- Relmada assuming responsibility for NDV-01's development, manufacturing, and commercialization following completion of the ongoing Phase 2 study
Relmada anticipates hosting an investor update on NDV-01's next development steps later in 2025.
Market Potential and Future Applications
Beyond its initial application as a first-line therapy for high-grade NMIBC, NDV-01 has potential for expanded use in patients who have failed other therapies, including BCG immunotherapy. The company is also exploring potential applications in other NMIBC subtypes, including intermediate-grade disease.
With bladder cancer survival rates ranging from 70-96% for early-stage disease but dropping to just 6% for advanced cases, effective early interventions like NDV-01 could significantly impact patient outcomes while addressing a substantial market opportunity.
As Relmada prepares to present the first clinical data for NDV-01 in April 2025, the medical community and investors will be watching closely to see if this novel formulation can deliver on its promise to transform the treatment landscape for non-muscle invasive bladder cancer.
