Relmada Therapeutics Licenses Phase 2 Bladder Cancer Drug NDV-01 from Trigone Pharma

Relmada Therapeutics, a clinical-stage biotechnology company, has recently finalized an exclusive licensing agreement with Trigone Pharma for NDV-01, a novel sustained-release intravesical formulation of gemcitabine and docetaxel. This innovative product is designed to treat Non-Muscle Invasive Bladder Cancer (NMIBC), which affects approximately 600,000 individuals in the U.S. annually, with about 62,000 new cases each year. The promising Phase 2 study results for NDV-01 are anticipated to be unveiled at the American Urological Association meeting scheduled for April 2025 in Las Vegas.

NDV-01 stands out due to its potential to become a first-line therapy for NMIBC. The formulation offers several advantages, including robust clinical evidence, a strong safety profile, simple dosing, and effective drug delivery. These features contribute to its applicability in both inpatient and outpatient settings, offering sustained drug delivery for up to 10 days compared to conventional treatments that last only a few hours.

Sergio Traversa, CEO of Relmada, expressed his enthusiasm for incorporating NDV-01 into the company's portfolio, highlighting its strategic alignment with the company's goal of developing high-value assets. Trigone's novel sustained-release formulation is expected to enhance NDV-01's adoption as a primary treatment for NMIBC due to its easy in-office administration and prolonged therapeutic effects on bladder tumors.

The Chief Financial Officer of Relmada, Maged Shenouda, highlighted that NDV-01 complements another recently acquired asset, sepranolone, which targets compulsion-related disorders. By adding both NDV-01 and sepranolone to its pipeline, Relmada aims to diversify its offerings while balancing risk and potential rewards, ultimately bringing these programs to patients swiftly.

Dr. Yair Lotan, a Urologic Oncology expert, noted the significant unmet need for effective treatments for NMIBC patients who do not respond to BCG therapy. The combination of gemcitabine and docetaxel has shown impressive efficacy in clinical studies with a manageable safety profile. The sustained-release formulation of NDV-01 ensures prolonged exposure to bladder tumors, enhancing anti-cancer effects and potentially improving patient compliance by reducing the burden associated with hospital-based treatments.

NDV-01 is currently undergoing evaluation in a Phase 2, single-arm study involving patients with high-grade NMIBC. The study aims to enroll up to 70 individuals, with preliminary data from the first 20 participants expected to be presented at the upcoming AUA meeting in Las Vegas.

Under the terms of the licensing agreement, Relmada will provide a $3.5 million upfront payment to Trigone and issue shares representing 10% of its outstanding stock for exclusive rights to NDV-01, excluding specific regions. Relmada will also be responsible for future development, manufacturing, and commercialization endeavors, with potential payments up to $200 million contingent on successful commercialization milestones.

NDV-01 employs a unique sustained-release mechanism, forming a soft matrix within the bladder to sequester and gradually release the drugs, maximizing local drug concentration while minimizing systemic toxicity. This approach differs from conventional intravesical treatments by avoiding peaks and troughs in drug concentration, ensuring a steady release over a 10-day period, thereby enhancing efficacy, reducing side effects, and improving patient compliance.

As NMIBC represents a significant portion of bladder cancer cases, with a high recurrence rate and limited treatment options, NDV-01 presents a substantial market opportunity. Its ease of administration, potential durability of action, and capacity to serve as a salvage treatment in various NMIBC subgroups further strengthen its prospects in the growing market for treatments of this condition.