■ Nicox SA said it has completed enrollment of patients in its multicenter, United States phase 2 clinical study evaluating NCX 470, a novel second-generation nitric oxide (NO)-donating bimatoprost analog, being tested in patients with open-angle glaucoma or OHTN for its ability to lower IOP. This study is a head-to-head comparison of once-daily administration of 3 different doses of NCX 470 vs latanoprost.
“We look forward to announcing the top-line results of this first efficacy phase 2 study of NCX 470, which we believe has the potential to be a new best-in-class treatment for the reduction of intraocular pressure in glaucoma patients in the US and worldwide,” said Michele Garufi, chairman and CEO of Nicox, in a news release. NCX 470 has demonstrated up to 3.5 mmHg greater IOP reduction than bimatoprost in head-to-head comparisons in preclinical models.
The multicenter, double-masked, parallel group, dose-response study aims to evaluate the efficacy and safety of NCX 470 ophthalmic solution compared to latanoprost ophthalmic solution 0.005% in patients with elevated IOP due to open-angle glaucoma or OHTN. The primary endpoint of the study is the mean reduction in diurnal IOP after 28 days of treatment, while the overall objective is to identify the appropriate dose of NCX 470 to be advanced into phase 3 clinical studies. Top-line data of the study are expected early in Q4 of 2019.