Nicox announced the initiation of a phase 2 clinical study evaluating NCX 470, its novel, second-generation nitric oxide (NO)-donating prostaglandin analog, for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension by enrolling 10 patients. NCX 470 is a new chemical entity which uses bimatoprost, a prostaglandin analog, as a scaffold for attaching an NO-donating moiety in order to achieve a dual mechanism of action. NCX 470 has demonstrated a 2 to 3 mmHg greater IOP reduction than bimatoprost alone, 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 United States. Nicox expects to report topline data from this phase 2 study in the second half of 2019.
This phase 2 multicenter, double-masked, 28-day, parallel group, dose ranging study aims to evaluate the efficacy and safety of NCX 470 compared to latanoprost 0.005% in adult patients with elevated IOP due to open-angle glaucoma or ocular hypertension. The study is expected to randomize 420 patients in clinical sites across the United States. The primary endpoint of the study is the mean reduction in diurnal IOP after 4 weeks of treatment, while the overall objective is to identify the appropriate dose of NCX 470 to be advanced into Phase 3 studies.
“Based on our preclinical data, we believe that NCX 470 may provide a clinically meaningful improvement over the current standard of care, and become a first-line therapy for these patients,” Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in a company news release. “The development of NCX 470 is testimony to the power of our efforts fueled by the seamless collaboration between our U.S. and European R&D teams, and follows on the back of the FDA approval of our first generation NO-donating compound VYZULTA, commercialized in the U.S. since last December by our partner Bausch + Lomb.”
This phase 2 study was initiated following the submission of an investigational new drug (IND) application in June 2018, ahead of the previously disclosed target date in the third quarter of 2018. The submitted IND has now successfully completed the 30-day review period by the FDA. Nicox’s NO-donating research platform has been validated through positive phase 3 results, and subsequent FDA approval and commercialization of Vyzulta (latanoprostene bunod ophthalmic solution), 0.024% by partner Bausch + Lomb.