Nicox SA announced that it has completed enrollment of patients in its multicenter, phase 2 clinical study evaluating NCX 470 nitric oxide (NO)-donating bimatoprost analog being tested in patients with open-angle glaucoma or ocular hypertension for its ability to lower IOP. This study is a head-to-head comparison of once-daily administration of three different doses of NCX 470 versus latanoprost, which is the most widely prescribed first-line therapy for glaucoma and ocular hypertension.
“We look forward to announcing the topline 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 U.S. and worldwide,” Michele Garufi, Chairman and CEO of Nicox, said in a company news release. “The timely execution of this study demonstrates that we are continuing to deliver on our strategy across our entire portfolio of product candidates in development.”
“We would like to thank all patients, clinical investigators, research coordinators, and all personnel from the participating clinical sites for their invaluable contributions to this study. As next steps, we expect the last patient to exit the study by the end of August, with the study on track for the topline efficacy results early in Q4 this year,” Tomas Navratil, PhD, Executive Vice President, Head of Development of Nicox, said in the news release.
Nicox’s lead product candidate, NCX 470, is a novel, second-generation NO-donating prostaglandin analog for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. NCX 470 has demonstrated up to 3.5 mmHg greater IOP reduction than bimatoprost in head-to-head comparisons in preclinical models. Bimatoprost, marketed under the brand Lumigan, is the current market leader by sales value among glaucoma therapies in the U.S.
The phase 2, multicenter, double-masked, 28-day, 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 ocular hypertension. 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. Topline data of the study are expected early in Q4 of this year.