Nicox Completes Recruitment for Denali Phase 3 Trial of NCX 470 in the U.S.
Nicox announced the recruitment and randomization of the final patient in the United States for its Denali Phase 3 trial of NCX 470. This milestone marks a significant step in evaluating the safety and efficacy of NCX 470 for patients with open-angle glaucoma or ocular hypertension.
Trial Details and Timeline
The Denali trial aims to assess the IOP-lowering efficacy of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005%. The study is being conducted across the U.S. and China, with Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea, and Southeast Asia, equally financing the trial. Topline results are expected in the second half of 2025, following the completion of recruitment in the U.S. and ongoing patient enrollment in China. To date, more than 95% of the targeted patient number have been randomized.
Company Statement
Doug Hubatsch, Chief Scientific Officer of Nicox, expressed gratitude for the support received: “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. 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.”
Regulatory and Trial Objectives
The Denali trial, along with the Mont Blanc trial, is designed to meet the regulatory requirements for a new drug application (NDA) submission of NCX 470 in both the U.S. and China. The NDA submission for NCX 470 in the U.S. is anticipated in the first half of 2026.
Previous Trial Results
Topline results from the Mont Blanc Phase 3 trial indicated that NCX 470 reduced intraocular pressure (IOP) from baseline by 8.0 to 9.7 mmHg, compared to 7.1 to 9.4 mmHg with latanoprost. Statistical noninferiority to latanoprost was achieved, and NCX 470 demonstrated superiority at 4 out of 6 timepoints. The Mont Blanc trial, published in the American Journal of Ophthalmology, showed that NCX 470 was well tolerated with low discontinuation rates.
