Nicox SA announced that over 40 sites have been initiated in the first month of the phase 3 Mont Blanc trial, evaluating NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. NCX 470 is the company’s novel, second-generation nitric oxide (NO)-donating bimatoprost analog.
“Based on the promising results from our phase 2 Dolomites trial, NCX 470 has the potential to offer patients with elevated IOP an improvement over the current standard of care,” Tomas Navratil, PhD, EVP & Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics, said in a company news release. “We expect to complete the adaptive dose selection of the NCX 470 dose by the end of 2020 paving the way for the remainder of the Mont Blanc trial and the start of our second phase 3 trial, Denali in 2020. We would like to thank the clinical investigators, research coordinators, all other trial personnel, and trial patients from the participating clinical sites for the rapid trial start-up and a strong first month of enrollment while carefully implementing COVID-19 precautions.”
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 approximately 670 patients at approximately 50 clinical sites, primarily in the U.S., and at a small number of clinical sites in China.
Nicox NCX 470 phase 3 program has received strong support from the U.S. glaucoma community, including the recently hosted a key opinion leader call on NCX 470 featuring a presentation by the current President of the American Glaucoma Society Dr. Donald Budenz, MD, MPH, Chair, Department of Ophthalmology, UNC Chapel Hill School of Medicine. A recording of the call can be found here.
Due to potential delays caused by COVID-19, the company is not currently providing a target date for the Mont Blanc topline results. Although we currently do not anticipate delays to our clinical timelines, we are closely monitoring the situation and will apprise the market if there is any impact on our development timelines.