Nicox SA announced that its partner, Ocumension Therapeutics, has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out the Chinese part of the ongoing Mont Blanc trial, the first phase 3 clinical trial on NCX 470 for the lowering of IOP in patients with open angle glaucoma or ocular hypertension.
NCX 470, Nicox’s lead clinical product candidate, is a novel second generation nitric oxide (NO)-donating bimatoprost analog exclusively licensed to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.
“We are pleased with this second Chinese IND approval in our collaboration with Ocumension. NCX 470 development remains on track, with first results from the Mont Blanc trial expected in Q4 2021,” Dr. José Boyer, VP and Interim Head of R&D at Nicox, said in a company news release. “Initiation of Chinese sites in this trial will be essential in preparing the way for Denali, the second phase 3 trial with NCX 470, which will include a larger number of Chinese patients.”
The NCX 470 Mont Blanc phase 3 clinical trial is a 3-month trial to evaluate 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 Mont Blanc trial is expected to randomize approximately 670 patients, at around 50 clinical sites in the U.S. and at a small number of clinical sites in China. The Mont Blanc trial was initiated in the U.S. in June 2020 and top-line results are currently expected in Q4 2021.
Nicox and Ocumension will jointly fund the second NCX 470 phase 3 glaucoma trial, Denali, which is expected to start by end of 2020 and will also evaluate NCX 470 ophthalmic solution 0.1% versus latanoprost ophthalmic solution, 0.005%. The Denali trial will include clinical sites in both the U.S. and China, with the large majority of the patients to be recruited in the U.S. The Denali trial was designed to fulfill the regulatory requirements to support new drug application (NDA) filings in the U.S. and China.