Biotech innovator Relmada Therapeutics has reported promising 12-month interim data from its Phase 2 trial of NDV-01 in high-risk non-muscle invasive bladder cancer (NMIBC), signalling a potential breakthrough for patients with limited treatment options.

 

The study showed a 76% complete response (CR) rate at 12 months, rising to 95% at any time for high-risk NMIBC patients. Among BCG-unresponsive patients, widely considered one of the toughest groups to treat, 80% achieved a 12-month CR and 94% achieved CR at any time.

 

Safety results were equally encouraging: no patients experienced Grade 3 or higher treatment-related adverse events, and no one discontinued therapy due to side effects.

 

“These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile,” said Raj S. Pruthi, Chief Medical Officer-Oncology of Relmada Therapeutics. 

 

“Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026.”

 

NDV-01’s design may help streamline treatment, according to experts. “I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation,” said Max Kates, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor.