Nicox announced that 50% of patients in the Mont Blanc NCX 470 phase 3 glaucoma clinical trial have now been randomized out of a target of 670, with topline results currently on track to be announced during Q2 2022.
“We have been successful in maintaining a good recruitment rate in the Mont Blanc trial through careful selection and support of clinical sites, despite the COVID-19 pandemic environment,” Dr. José Boyer, Interim Head of R&D at Nicox, said in a company news release. “This milestone of randomizing 50% of the total planned patients in the trial indicates that we are currently on track for topline results for this first phase 3 trial in the second quarter of 2022. The Mont Blanc trial is key to demonstrating the safety and efficacy profile of NCX 470 as potentially the first non-fixed-combination to be submitted for approval using a pivotal trial showing a statistically superior reduction of intraocular pressure over the standard of care, latanoprost.”
Nicox’s lead clinical product candidate, NCX 470, is a novel nitric oxide (NO)-donating prostaglandin analog licensed exclusively to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets. Mont Blanc is a 3-month multi-regional phase 3 clinical trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The Mont Blanc trial was initiated in the U.S. in June 2020 with an initial adaptive design portion wherein the highest dose of NCX 470 tested in the Dolomites phase 2 clinical trial, 0.065%, was evaluated together with a higher 0.1% concentration of NCX 470. The 0.1% dose of NCX 470 was selected in the adaptive stage of the Mont Blanc trial and enabled the second part of the Mont Blanc phase 3 trial and the start of Denali phase 3 trial.
Denali, the second multi-regional phase 3 clinical trial of NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. in November 2020, and approval was recently obtained to start recruitment in China. Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% that will also include a long-term safety extension. The trial is financed jointly and in equal parts by Nicox and Ocumension and includes clinical sites in both the U.S. and China, with the majority of the patients to be recruited in the U.S. Topline efficacy results are currently expected in Q4 2022.
The Denali trial, together with the ongoing Mont Blanc trial, are designed to fulfill the regulatory requirements for phase 3 safety and efficacy trials to support new drug application (NDA) submissions in the U.S. and China.