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Nicox Reaches 50% Enrollment Threshold in U.S. Phase 2 Study with NCX 470 Ahead of Schedule
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January 8, 2019 - release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced it has reached the 50% patient enrollment threshold of its multicenter, United States (U.S.) Phase 2 clinical study evaluating NCX 470 ahead of schedule. Nicox's lead product candidate, NCX 470, is a novel, second-generation nitric oxide (NO)-donating prostaglandin analog for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. NCX 470 has demonstrated a 2 to 3 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 study is expected to randomize 420 patients in clinical sites across the U.S. 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.
Tomas Navratil, PhD, Executive Vice President, Head of Development of Nicox, said: "We are encouraged by the brisk patient recruitment rate of our NCX 470 Phase 2 study, and we are grateful for the support and the commitment of the patients and clinical sites in the NCX 470 study. We believe that NCX 470 has the potential to become a leading first-line therapy for glaucoma patients due to its IOP lowering superiority versus the market leader as demonstrated in preclinical models."
Nicox expects to report top-line data from this Phase 2 study in the second half of 2019.
...............................................
January 8, 2019 - release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced it has reached the 50% patient enrollment threshold of its multicenter, United States (U.S.) Phase 2 clinical study evaluating NCX 470 ahead of schedule. Nicox's lead product candidate, NCX 470, is a novel, second-generation nitric oxide (NO)-donating prostaglandin analog for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. NCX 470 has demonstrated a 2 to 3 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 study is expected to randomize 420 patients in clinical sites across the U.S. 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.
Tomas Navratil, PhD, Executive Vice President, Head of Development of Nicox, said: "We are encouraged by the brisk patient recruitment rate of our NCX 470 Phase 2 study, and we are grateful for the support and the commitment of the patients and clinical sites in the NCX 470 study. We believe that NCX 470 has the potential to become a leading first-line therapy for glaucoma patients due to its IOP lowering superiority versus the market leader as demonstrated in preclinical models."
Nicox expects to report top-line data from this Phase 2 study in the second half of 2019.
