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Relmada Therapeutics To Present NDV-01 Data at American Urology Association On April 28, 2025

Benzinga·04/14/2025 11:36:38
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CORAL GABLES, Fla., April 14, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (NASDAQ:RLMD, "Relmada", "the Company"))), a clinical-stage biotechnology company, today announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas.

Abstract Overview
Abstract Title: Prospective Open Label Study to Evaluate the Safety and Efficacy of Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBC: P2 on Apr 25
Session: P2 (Paradigm-Shifting)
Presentation Date: April 28, 2025
Presentation Time 10:04 AM PT

About NDV-01

NDV-01 is an investigational, innovative sustained-release formulation of two complementary, well-established, chemotherapy agents, gemcitabine and docetaxel (gem/doce). It is designed for intravesical dosing and intended to be an in-office ready-to-use therapy that is administered rapidly and requires no anesthesia or new or dedicated equipment to employ. NDV-01 forms a spherical soft matrix within the bladder that sequesters drug and releases it as the matrix gradually dissolves.

NDV-01's formulation is specifically designed to maximize local drug concentration and prolong exposure to gem/doce, while minimizing systemic toxicity. Unlike conventional intravesical instillations, NDV-01 is designed to avoid peaks and troughs in drug concentration, ensuring a gradual and sustained release of gem/doce over a 10-day period. This approach may potentially enhance overall efficacy, reduce side effects, reduce the frequency of dosing and improve patient compliance and outcomes. NDV-01 has the potential to be a first line (1L) therapy for HG-NMIBC, with further potential for use in patients who have failed other therapies, including BCG immunotherapy, and expansion into other NMIBC subtypes, including intermediate-grade disease.

NDV-01 is protected by several patents that go out to 2038.