Nicox announced that it has successfully completed an end-of-phase 2 meeting with the FDA and agreed on the design for the NCX 470 phase 3 program, as well as nonclinical and CMC plans supporting submission of a new drug application (NDA) in the U.S. NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, is Nicox’s lead clinical development program.
In the multicenter, phase 2 clinical trial (Dolomites) conducted in the U.S., NCX 470 demonstrated both statistical noninferiority and superiority to latanoprost, the U.S. 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 highest reduction seen in a glaucoma clinical trial with an eye drop.
“Our meeting with the U.S. FDA has clarified the path forward for NCX 470 to a future NDA submission. With this input from the FDA, we are on track to initiate the first pivotal clinical trial by the end of Q2 2020,” Tomas Navratil, PhD, EVP & Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics, said in a company news release. “We would like to thank the U.S. FDA ophthalmic division for a productive end-of-phase 2 meeting. We look forward to further demonstrating in our phase 3 program the potential of NCX 470 as the best-in-class molecule for the lowering of intraocular pressure in glaucoma patients.”
The Mont Blanc trial, the first phase 3 clinical trial of NCX 470, is expected to start by the end of Q2 2020, with topline results expected in Q3 2021. As disclosed previously, the Mont Blanc trial will be initiated with 0.065% and 0.1% doses of NCX 470, with one dose being selected during the trial through an adaptive design. Additional details of the trial design will be disclosed following the initiation of the trial.