Relmada’s NDV-01 Shows 76% 12-Month CR Rate and 95% Peak Response
Relmada’s NDV-01 achieved a 76% complete response rate at 12 months and 95% at any time in high-risk NMIBC patients, including 80% at 12 months in BCG-unresponsive cases, with no Grade 3+ treatment-related adverse events. These results pave the way for a Phase 3 RESCUE program initiation in mid-2026.
1. Phase 2 Interim Data
The ongoing Phase 2 trial enrolled 48 high-risk NMIBC patients, reporting a 12-month complete response (CR) rate of 76% and a 95% any-time CR rate among 38 evaluable subjects. A Kaplan-Meier analysis estimated an 83% CR durability at 12 months, underscoring sustained efficacy.
2. Efficacy in BCG-Unresponsive Subgroup
In the BCG-unresponsive subgroup of 20 patients, NDV-01 achieved an 80% 12-month CR rate and a 94% any-time CR rate, with an 84% Kaplan-Meier estimate at 12 months. Notably, no patients progressed to muscle-invasive disease or required radical cystectomy during follow-up.
3. Safety Profile
NDV-01 demonstrated a favorable tolerability profile with no Grade 3 or higher treatment-related adverse events and zero treatment discontinuations. Among 48 dosed patients, 63% experienced mostly transient Grade 1 dysuria, while 8% had asymptomatic positive urine cultures and 8% reported hematuria.
4. Phase 3 RESCUE Planning
These durable responses and clean safety data support advancement into the Phase 3 RESCUE registrational program in mid-2026. The program includes an open-label randomized trial in adjuvant intermediate-risk NMIBC and a single-arm second-line trial for BCG-unresponsive patients.