Top Line Results from Glaucoma Dolomites Phase 2 Trial Show Nicox’s NCX 470 Meets Primary Endpoint and Demonstrates Statistical Superiority vs Latanoprost
October 2, 2019
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NCX 470 met the primary endpoint of non-inferiority and also demonstrated superiority to latanoprost, the U.S. market leader in prostaglandin analog prescriptions, in multiple pre-specified analyses
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Intraocular pressure (IOP) lowering effect from baseline of NCX 470 was 7.6 to 9.8 mmHg
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All doses of NCX 470 were well tolerated with no drug-related serious adverse events
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced positive topline results from its U.S. multicenter, Dolomites dose-response Phase 2 clinical trial evaluating investigational NCX 470, a novel second-generation nitric oxide (NO)-donating bimatoprost analog, compared to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension.
Michele Garufi, Chairman and CEO of Nicox, said “We are very pleased that NCX 470 0.065% demonstrated statistical superiority to latanoprost in a pre-specified secondary efficacy analysis. If these results are confirmed in Phase 3 clinical trials, NCX 470 could potentially become the first non-combination product with statistical superiority to a prostaglandin analog. Moreover, NCX 470 has demonstrated what we believe to be the highest IOP reduction from baseline in a glaucoma clinical trial with up to 9.8 mmHg in time-matched IOP. We are planning an end-of-phase 2 meeting with the FDA early next year to finalize plans to conduct the Phase 3 trials against a prostaglandin analog.”
NCX 470 Dolomites Phase 2 Trial Summary
- Statistical non-inferiority was met vs. latanoprost in the primary efficacy analysis (mean diurnal IOP reduction from baseline at Day 28)
- IOP lowering effect of NCX 470 0.065% from baseline was 7.6 to 9.8 mmHg vs. 6.3 to 8.8 mmHg for latanoprost (reduction in time-matched IOP at 8 AM, 10 AM and 4 PM across all visits)
- Statistical superiority was met with NCX 470 0.065% being up to 1.4 mmHg superior to latanoprost in a pre-specified secondary efficacy analysis of time-matched IOP at 8 AM, 10 AM and 4 PM at Day 28 (p<0.025)
- NCX 470 was well tolerated; the most frequent adverse event was conjunctival hyperemia in 16.8% of the NCX 470 0.065% patients vs. 6.5% of latanoprost patients, with most events rated as mild; and there were no drug-related serious adverse events and no evidence of treatment-related systemic effects
Dr. Donald L. Budenz, MD, Chairman of Ophthalmology at University of North Carolina at Chapel Hill and member of Nicox Glaucoma Clinical Advisory Board, stated: “Based on the current encouraging results, NCX 470 has the potential to become a key part of the standard of care for the physicians treating patients with open-angle glaucoma or ocular hypertension.”
“We would like to acknowledge and thank all patients, clinical investigators and their teams for their contributions to the Dolomites study. The current dose response curve of NCX 470 shows improved IOP lowering with each incremental concentration of NCX 470 tested, which creates the potential for additional IOP lowering at higher doses to be evaluated in future trials.” said Tomas Navratil, PhD, Executive Vice President, Head of Development of Nicox.