Nicox’s NCX 470 Mont Blanc Phase 3 Glaucoma Trial Reaches 50% Enrollment Milestone

Press Release

Nicox’s NCX 470 Mont Blanc Phase 3 Glaucoma Trial Reaches 50% Enrollment Milestone

338 patients randomized as of March 22, 2021, out of a target of 670 Currently on track for top-line results in Q2 2022 March 23, 2021 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that 50% of patients in the Mont Blanc NCX 470 Phase 3 glaucoma clinical trial have now been randomized out of a target of 670, with top-line results currently on track to be announced during Q2 2022.

 

Dr. José Boyer, Interim Head of R&D at Nicox, said: “We have been successful in maintaining a good recruitment rate in the Mont Blanc trial through careful selection and support of clinical sites, despite the COVID-19 pandemic environment.  This milestone of randomizing 50% of the total planned patients in the trial indicates that we are currently on track for top-line results for this first Phase 3 trial in the second quarter of 2022.  The Mont Blanc trial is key to demonstrating the safety and efficacy profile of NCX 470 as potentially the first non-fixed-combination to be submitted for approval using a pivotal trial showing a statistically superior reduction of intraocular pressure over the standard of care, latanoprost.”

Nicox’s lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets.   Mont Blanc is a 3-month multi-regional Phase 3 clinical trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005%, for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.  The Mont Blanc trial was initiated in the U.S. in June 2020 with an initial adaptive design portion wherein the highest dose of NCX 470 tested in the Dolomites Phase 2 clinical trial, 0.065%, was evaluated together with a higher 0.1% concentration of NCX 470.  The 0.1% dose of NCX 470 was selected in the adaptive stage of the Mont Blanc trial and enabled the second part of the Mont Blanc Phase 3 trial and the start of Denali Phase 3 trial.