Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Denali Phase 3 Trial
March 4, 2021
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner, Ocumension Therapeutics, has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct the Chinese part of the ongoing NCX 470 Denali Phase 3 clinical trial for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
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 South East Asian markets.
Dr. José Boyer, Interim Head of R&D at Nicox, said: “This approval allows us to initiate Chinese patients in the Denali trial on schedule. This will pave the way for Nicox and Ocumension to submit New Drug Applications in parallel in the U.S. and China, respectively, and potentially bring NCX 470 to these two important markets in similar timeframes.”
The Press Release by Ocumension can be found here.
Denali, the second Phase 3 trial of NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. on November 9, 2020. Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% and 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. 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. Top-line results are currently expected in Q4 2022.
NCX 470 is also being studied in Mont Blanc, a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Top-line results are currently expected in H1 2022.