Nicox is finalizing the design of a first-in-human trial for NCX 470, its novel nitric oxide donating bimatoprost analog being developed for intraocular pressure lowering, according to a press release.
Nicox held a pre-Investigational New Drug meeting with the FDA at the end of 2016.
The feedback from the meeting will contribute to the design of the trial for NCX 470, which will be a phase 2 multicenter, investigator-masked, 28-day, parallel group, dose-finding study in adults with elevated IOP due to open-angle glaucoma or ocular hypertension.
The safety and efficacy of multiple doses of NCX 470 will be compared to bimatoprost, according to the release.
The primary endpoint will be mean reduction in IOP, and the objective is to identify the appropriate and effective dose of NCX 470 to be taken into phase 3 studies, the company reported.
Subject recruitment is to begin in early 2018, subject to IND filing and acceptance, and Nicox expects the study to take about 1 year to complete.