Nicox Initiates Second Phase 3 Trial of NCX 470 in Glaucoma

Nicox announced the initiation of the second phase 3 clinical trial of NCX 470 (Denali) evaluating NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The first patients were enrolled in the U.S. on November 9, 2020.

NCX 470, Nicox’s lead clinical product candidate, is a novel second-generation nitric oxide (NO)-donating bimatoprost analog. The Denali trial will be financed jointly and in equal parts by Nicox and Ocumension Therapeutics, Nicox’s exclusive licensee for the Chinese, Korean and South East Asian markets.

“The Denali trial is the second pivotal trial required for the new drug applications of NCX 470 in both the United States and China,” Dr. José Boyer, VP and Interim Head of R&D at Nicox, said in a company news release. “With this initiation, our NCX 470 development program is entering the final phase and remains on track. 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 U.S. and China, to ensure a timely and efficient execution of this multi-regional trial”.

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 trial, which will also include a long-term safety extension, is expected to randomize 650+ patients at approximately 50 clinical sites in the U.S. and China, with a majority to be recruited in the U.S. The Denali trial was designed to fulfill the regulatory requirements to support NDA submissions of NCX 470 in the U.S. and China.

The first phase 3 trial of NCX 470 is the ongoing Mont Blanc trial which was initiated in the U.S. in June 2020, with topline results currently expected in Q4 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 randomize approximately 670 patients, at approximately 50 clinical sites in the U.S. 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.

We continue to closely watch 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.