Nicox SA has announced the full enrollment of its Denali Phase 3 clinical trial in China, evaluating NCX 470 for patients with open-angle glaucoma or ocular hypertension. This milestone, achieved ahead of schedule, ensures that the target number of patients for the trial has been met, following the completion of recruitment in the United States in July 2024. Topline results from the Denali trial are anticipated in Q3 2025.
The Denali trial is a multi-center, international study assessing the efficacy and safety of a once-daily dose of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005%. The trial is jointly financed by Nicox and Ocumension, Nicox's licensee for China, Korea, and Southeast Asia.
NCX 470: A Novel Approach to IOP Reduction
NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop designed to lower intraocular pressure (IOP) through two distinct pathways. It combines Nicox's NO-donating research platform with bimatoprost in a single molecule. By releasing both bimatoprost and NO into the eye, NCX 470 aims to enhance aqueous humor drainage and IOP reduction, leveraging the well-established IOP-lowering effects of prostaglandin analogs (PGAs) like bimatoprost and the additional benefits of NO.
Mont Blanc Trial: Promising Efficacy and Safety Data
Data from the Mont Blanc trial, the first Phase 3 study of NCX 470, demonstrated a significant IOP-lowering effect from baseline, ranging from 8.0 to 9.7 mmHg for NCX 470 compared to 7.1 to 9.4 mmHg for latanoprost. The trial met its primary efficacy endpoint, demonstrating statistical non-inferiority to latanoprost, with superiority shown at 4 out of 6 timepoints. NCX 470 was also well-tolerated, with low discontinuation rates. These results have been published in the American Journal of Ophthalmology.
Regulatory and Commercialization Strategy
The Denali and Mont Blanc trials are designed to meet the clinical regulatory requirements for New Drug Application (NDA) submissions in both the U.S. and China. Nicox estimates that a U.S. NDA for NCX 470 could potentially be submitted in the first half of 2026, contingent on securing a commercialization partnership in the U.S. or obtaining appropriate financing.
"Following completion of the recruitment of the Denali trial in the United States, we have seen an acceleration in the number of Chinese patients randomized in this multi-center international trial, allowing us to close Chinese patient recruitment earlier than expected," said Doug Hubatsch, Chief Scientific Officer of Nicox. Emmet Purtill, VP Business Development, added, "NCX 470 continues to generate interest from potential commercialisation partners. With strong collaborations in Japan, China, Korea and Southeast Asia already in place, we are focussing on the route to commercialisation for NCX 470 in the United States, with potential for regional partnerships elsewhere."
