Nicox Completes Enrollment of the Adaptive Design Cohort of NCX 470 Mont Blanc Phase 3 Glaucoma Trial

September 2, 2020

  • Adaptive dose selection paves the way for the second part of Mont Blanc Phase 3 trial, and the start of the second Phase 3 trial, Denali

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it completed enrollment of the adaptive design patient cohort in its multicenter Mont Blanc Phase 3 trial, evaluating NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution, 0.005% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.  NCX 470 is the company’s novel, second-generation nitric oxide (NO)-donating bimatoprost analog.

The adaptive design portion of the trial is intended to select the optimal dose of NCX 470 for the subsequent head-to-head 3-month safety and efficacy evaluation of NCX 470 vs. latanoprost, the current U.S. standard of care for patients with open-angle glaucoma and ocular hypertension.

Tomas Navratil, PhD, EVP & Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics, Inc., said, “The strong enrollment in the first three months of the Mont Blanc Phase 3 trial was driven by enthusiastic support from our clinical sites and high level of interest from eligible patients.  As a result, we expect to be able to select the optimal dose of NCX 470 in the coming weeks for the remainder of the Mont Blanc trial as well as for the start of our second Phase 3 trial, Denali, before the end of 2020.  We would like to thank the clinical investigators, research coordinators, all other trial personnel, and patients for their support.

The Mont Blanc trial is a multi-regional, double-masked, 3-month, parallel group, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1%, compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension.  The primary efficacy evaluation is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3.  The trial is expected to randomize approximately 670 patients at approximately 50 clinical sites, primarily in the U.S., and at a small number of clinical sites in China.

COVID-19 Situation

Due to potential delays caused by COVID-19, the Company is not currently providing a target date for the Mont Blanc topline results.  Although we currently do not anticipate delays to our clinical timelines, we are closely monitoring the situation and will apprise the market if there is any impact on our development timelines.

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