Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the initiation of the first Phase 3 clinical trial, named Mont Blanc, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, by enrolling the first 12 patients yesterday. NCX 470 is the company’s novel, second-generation nitric oxide (NO)-donating bimatoprost analog.
The Mont Blanc trial is a multi-regional, double-masked, 3-month, parallel group, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension. In an adaptive portion of the trial, one NCX 470 dose will be selected to continue in the subsequent head-to-head 3-month safety and efficacy evaluation of NCX 470 vs. latanoprost. The primary efficacy evaluation is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3. The trial is expected to randomize 600+ patients, primarily at clinical sites in the U.S. and at a small number of clinical sites in China.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “The initiation of the Mont Blanc trial is a pivotal step forward for Nicox. The Dolomites Phase 2 trial has already shown that we have an excellent product candidate in our hands by demonstrating that NCX 470 0.065% is statistically superior vs. latanoprost in IOP lowering. NCX 470 is Nicox’s lead product candidate and value driver, with the potential to be an improvement over the current standard of care for patients with elevated IOP.”
Tomas Navratil, PhD, EVP & Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics, Inc., said, “We have assembled a group of top glaucoma clinical investigators who are enthusiastic to participate in the Mont Blanc trial, based on the promising NCX 470 results from our Phase 2 Dolomites trial. The adaptive design of the Mont Blanc trial will allow us to select the optimal NCX 470 dose for the remainder of the trial and, shortly thereafter, to start our second Phase 3 trial, Denali. Both of these pivotal trials benefit from agreement by the U.S. Food and Drug Administration to conduct the primary efficacy analysis based on time-matched IOPs at 8 AM and 4 PM, rather than the traditional 8 AM, 10 AM and 4 PM measurements, due to Nicox’s use of latanoprost as the active comparator in both the Mont Blanc and Denali trials.”
In the Phase 2 Dolomites trial, NCX 470 demonstrated both statistical non-inferiority and superiority to latanoprost, the U.S. standard of care for patients with open-angle glaucoma and ocular hypertension, and the market leader in prostaglandin analog prescriptions. We believe the 7.6 to 9.8 mmHg IOP reduction from baseline at 8 AM, 10 AM and 4 PM across the Week 1, 2 and 4 Visits in the Dolomites trial is the highest reduction demonstrated by an eye drop in a glaucoma clinical trial.
