Nicox Completes Patient Enrollment for Denali Phase 3 Trial of NCX 470 in China

Nicox has announced the completion of patient enrollment in China for the Denali Phase 3 trial, which evaluates the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension. The screening process in China is now officially closed. This milestone follows the completion of patient recruitment in the United States, achieved in July 2024, meeting the trial's overall target enrollment.

Topline results from the Denali trial are expected in Q3 2025.

Accelerated Recruitment in China

“Following the completion of recruitment in the United States, we observed an acceleration in the number of Chinese patients randomized in this multicenter international trial, enabling us to close Chinese patient recruitment ahead of schedule,” stated Doug Hubatsch, Chief Scientific Officer of Nicox.

He added, “While we continue the final stages of this trial, we are also completing additional development steps to support the preparation of new drug applications (NDAs) in both the United States and China. This will ensure submission as soon as possible after the Denali topline data is received.”

Strategic Commercialization Plans

NCX 470, Nicox’s lead product candidate, is garnering strong interest from potential commercialization partners. According to Emmet Purtill, VP of Business Development at Nicox:
“Collaborations for NCX 470 in Japan, China, Korea, and Southeast Asia are already in place. Our current focus is on the path to commercialization in the United States, while exploring potential regional partnerships in other markets.”

About the Denali Trial

The Denali trial is a multicenter, multinational Phase 3 clinical trial conducted in the United States and China. It assesses the intraocular pressure (IOP)–lowering efficacy of:

       • NCX 470 ophthalmic solution 0.1% (administered once daily)

       • Compared to latanoprost ophthalmic solution 0.005%

The trial is a collaborative effort, co-financed by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea, and Southeast Asia. Together with the Mont Blanc trial, the Denali trial is designed to meet the clinical regulatory requirements for NDAs in the United States and China.

Key Data from Mont Blanc Trial

The Mont Blanc Phase 3 trial previously demonstrated that NCX 470 achieved significant IOP-lowering effects:

       • Reduction in IOP from baseline:

               - 8.0–9.7 mmHg for NCX 470

               - Compared to 7.1–9.4 mmHg for latanoprost

The trial met the U.S. regulatory efficacy requirements, achieving statistical noninferiority to latanoprost and demonstrating superiority at 4 out of 6 timepoints.

Additional highlights:

       • NCX 470 was well tolerated.

       • Discontinuation rates were low.

       • Results have been published in the American Journal of Ophthalmology.

Next Steps for NCX 470

The Denali trial data, combined with findings from Mont Blanc, will form the basis for NDA submissions in both the U.S. and China. Nicox estimates that a U.S. NDA for NCX 470 could be submitted by H1 2026, contingent upon securing a commercialization partnership or appropriate financing.

With a robust clinical profile and strong partnerships in key regions, NCX 470 is positioned as a promising therapeutic option for managing open-angle glaucoma and ocular hypertension.