Nicox Announces Recruitment of Last Patient in US in Denali Phase 3 Trial of NCX 470
Nicox announced the recruitment and randomization of the last patient in the United States in its Denali phase 3 trial of NCX 470.
The Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension. According to Nicox, topline results continue to be expected in H2 2025 based on this completion of recruitment of patients in the US and continuing good progress of the trial in China, where recruitment of patients is still ongoing. More than 95% of the total target number of patients have been randomized in this trial so far.
“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.” said Doug Hubatsch, Chief Scientific Officer of Nicox.
The Denali trial is evaluating the IOP lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the Mont Blanc trial, was designed to fulfill the regulatory requirements to support new drug application (NDA) submissions of NCX 470 in the U.S. and China. The US NDA for NCX 470 is expected to be submitted in H1 2026.
Topline results from the first phase 3 trial, Mont Blanc, showed the IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost. Statistical noninferiority was met vs. 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 US NCX 470 was well tolerated and discontinuation rates were low, according to Nicox. The results of the Mont Blanc trial have been published in the American Journal of Ophthalmology, and numerous post hoc analyses have been presented. Full details of all presentations and publications can be found at nicox.com/pipeline-markets-and-science/#publications.