The first phase 3 clinical trial of NCX 470 (Nicox) for lowering of IOP in patients with open-angle glaucoma or ocular hypertension (Mont Blanc) is currently expected to start by the end of Q2 2020, with top-line results expected in Q3 2021. The Mont Blanc trial will be conducted principally in clinical sites in the United States and will include a small number of Chinese clinical sites. The trial will be initiated with 0.065% and 0.1% doses of NCX 470 vs latanoprost 0.005%, with only 1 dose of NCX 470 being selected through an adaptive design to complete the trial.
NCX 470 is a novel second-generation nitric oxide (NO)-donating bimatoprost analog, and it is Nicox’s lead clinical development program. In a multicenter, phase 2 clinical trial (Dolomites) conducted in the United States, NCX 470 demonstrated both statistical noninferiority and superiority to latanoprost, the US market leader in prostaglandin analog prescriptions. Nicox believes the 7.6- to 9.8-mmHg IOP reduction from baseline at 8 am, 10 am, and 4 pm across the week 1, 2, and 4 visits is the greatest reduction seen in a glaucoma clinical trial with an eyedrop.
The second phase 3 glaucoma clinical trial (Denali), jointly managed and equally funded by Nicox and Ocumension, is currently expected to start in the second half of 2020. It will include clinical sites in both the United States and China, with the majority of the patients in the United States to support the US New Drug Application (NDA) filing. A sufficient number of patients from China will be included in the Denali trial to support an NDA filing in China.