Nicox’s Denali Phase 3 Trial of NCX 470 Fully Enrolled in China
Nicox announced that its Denali phase 3 trial evaluating the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension is now fully enrolled in China and screening has been closed. Completion of recruitment of patients in the US for the trial was announced in July 2024 and therefore the target number of patients to be enrolled in the Denali trial has been met, according to Nicox.
Topline results are expected in the third quarter of 2025.
“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 multicenter international trial, allowing us to close Chinese patient recruitment earlier than expected,” Doug Hubatsch, Chief Scientific Officer of Nicox, said in a company news release. "Whilst we continue the final stages of this trial, we are also completing the additional development steps necessary to support the preparation of new drug applications in both the United States and China to ensure that these could be submitted as soon as possible after the receipt of the Denali topline data.”
“NCX 470 continues to generate interest from potential commercialization partners. With 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,” said Emmet Purtill, VP Business Development.
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 clinical regulatory requirements to support new drug application (NDA) submissions of NCX 470 in the US and China. The company estimates that a US NDA for NCX 470 could potentially be submitted in H1 2026, subject to the company entering into a partnership for the commercialization of NCX 470 in the U.S. or obtaining appropriate financing.
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 U.S. NCX 470 was well tolerated and discontinuation rates were low. 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.