Phase 3 trial kicks off for glaucoma candidate

Nicox SA, an international ophthalmology company, has kicked off the second Phase 3 clinical trial of NCX 470, evaluating for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.

The Denali Phase 3 clinical trial will include more than 650 randomly assigned patients at about 50 clinical sites across the US and China, and will be funded by Nicox and Ocumension Therapeutics.

With the Mont Blanc Phase 3 trial, Denali will support the new drug application (NDA) submissions in the US and China. The first patients were enrolled in the US on Nov. 9.

In a statement, José Boyer, vice president and interim head of research and development at Nicox, noted that the Denali trial is the second pivotal trial for the NDA of NCX 470 in the US and China.

“With this initiation, our NCX 470 development program is entering the final phase and remains on track,” he said. “We have assembled a strong and experienced in-house development team in the glaucoma space and have selected an international clinical research organization with a strong presence in both the US and China, to ensure a timely and efficient execution of this multi-regional trial”.

According to the company’s statement, Denali is a 3-month Phase 3 trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.

The Denali trial was designed to fulfill the regulatory requirements to support NDA submissions of NCX 470 in the US and China.

The Denali trial comes on the heels of the ongoing Mont Blanc trial, which was initiated in the US in June, with top-line results currently expected in during the fourth quarter of 2021.

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, is expected to randomly assign approximately 670 patients, at about 50 clinical sites in the US and a small number of clinical sites in China. 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.

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