Mont Blanc Phase 3 glaucoma trial reaches 50% enrollment milestone

Nicox SA, an international ophthalmology company, announced this week that 50% of patients in the Mont Blanc NCX 470 Phase 3 glaucoma clinical trial have now been randomly assigned out of a target of 670, with top-line results currently on track to be announced during the second quarter of 2022.

The trial will include about 50 clinical sites across the US and China, and will be funded by Nicox and Ocumension Therapeutics.

According to José Boyer, interim head of research and development at Nicox, the company has 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. 

“This milestone of randomizing 50% of the total planned patients in the trial indicates that we are currently on track for top-line results for this first Phase 3 trial in the second quarter of 2022,” he said in a statement. “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.

The 3-month Mont Blanc trial, also 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. Ocumension recently received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out the Chinese part of Mont Blanc trial.

The Mont Blanc trial was initiated in the US 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. Top-line 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 US and China.

In its statement, the company noted that it continues to monitor the spread and impact of the COVID-19 pandemic.

“We do not currently anticipate delays in our clinical timelines, but we are monitoring the situation and will provide an update when needed,” they said in the release.