Globenewswire·2026-03-09 11:00Core Insights - Relmada Therapeutics announced promising 12-month interim data from its Phase 2 trial of NDV-01 for high-risk non-muscle invasive bladder cancer (NMIBC), showing a complete response (CR) rate of 76% and an 80% CR rate in the BCG-unresponsive population, indicating potential for a best-in-class profile [1][2][6] Clinical Results - The Phase 2 trial demonstrated a 12-month complete response rate of 76% in the overall population and 80% in the BCG-unresponsive subgroup [2][6] - The complete response rates at various time points were: 95% at any time, 87% at 3 months, 86% at 6 months, 85% at 9 months, and 76% at 12 months [4] - In the BCG-unresponsive subgroup, the complete response rates were 94% at any time, 82% at 3 months, 86% at 6 months, and 91% at 9 months [5] Safety Profile - NDV-01 exhibited a favorable safety profile with no patients experiencing Grade 3 or higher treatment-related adverse events and no treatment-related discontinuations [6][12] - Among the 48 patients, 63% experienced treatment-related adverse events, primarily transient dysuria [12] Future Development Plans - The interim results support advancing NDV-01 into the Phase 3 RESCUE registrational program, expected to initiate in mid-2026, with two pathways: one for adjuvant intermediate-risk NMIBC and another for second-line BCG-unresponsive NMIBC [3][8] - The Phase 3 program aims to address significant unmet needs in the NMIBC market, particularly for patients with limited treatment options [13] Product Overview - NDV-01 is a sustained-release formulation of gemcitabine and docetaxel designed for intravesical administration, allowing for gradual drug release over 10 days [9] - The formulation is convenient to administer in approximately 5 minutes without the need for anesthesia or specialized equipment, enhancing its potential for broad adoption in clinical settings [9]