Nicox SA has announced the recruitment and randomization of the final patient in the United States for its Denali Phase 3 trial of NCX 470, marking a significant milestone in the development of this novel nitric oxide-donating bimatoprost eye drop for patients with open-angle glaucoma or ocular hypertension.
Trial Progress and Design
The Denali trial is evaluating the intraocular pressure (IOP) lowering efficacy of once-daily NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005%. The multi-country study is being conducted across the United States and China, with Nicox and Ocumension, Nicox's exclusive licensee for China, Korea, and Southeast Asia, equally financing the trial.
More than 95% of the total target number of patients have been randomized in the trial to date. While U.S. recruitment is now complete, patient enrollment continues in China as the company works toward full trial completion.
Timeline and Regulatory Strategy
Topline results from the Denali trial are expected in the second half of 2025, based on the completion of U.S. recruitment and continuing progress in China. The Denali trial, together with the previously completed Mont Blanc trial, was designed to fulfill regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in both the United States and China.
The U.S. NDA for NCX 470 is anticipated to be submitted in the first half of 2026, representing a critical step toward potential market approval for this novel glaucoma treatment.
Previous Trial Success
The first Phase 3 trial, Mont Blanc, has already demonstrated promising efficacy results. The IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 compared to 7.1 to 9.4 mmHg for latanoprost. Statistical non-inferiority was met versus latanoprost in the primary efficacy analysis, and 4 out of 6 timepoints additionally demonstrated superiority. The trial therefore met the efficacy requirements for approval in the United States.
NCX 470 was well tolerated in the Mont Blanc trial, with low discontinuation rates reported.
Company Perspective
Doug Hubatsch, Chief Scientific Officer of Nicox, expressed appreciation for the collaborative effort that enabled this milestone. "I would like to thank our patients, the clinical sites, our internal team, and our investors for their efforts and support in enabling us to reach this important milestone, the completion of U.S. recruitment in the Denali trial," Hubatsch stated.
"We will remain fully focused on NCX 470 and on continuing recruitment of patients in China to complete Denali as we move towards expected topline results in H2 2025," he added.
The completion of U.S. recruitment represents a significant step forward for NCX 470, which offers a novel approach to glaucoma treatment through its nitric oxide-donating mechanism combined with bimatoprost's established IOP-lowering properties.
