Nicox Initiates Phase 2 Trial of NCX 4251 in Blepharitis
Nicox SA announced the initiation of a phase 2 clinical trial evaluating NCX 4251,its novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. Nicox expects to report topline results from this phase 2 trial in the fourth quarter of 2019.
This phase 2 multicenter, randomized, double-masked, placebo-controlled, dose-escalation, 14-day trial aims to evaluate the safety and tolerability of NCX 4251 compared to placebo in patients with acute exacerbations of blepharitis. The trial is expected to randomize approximately 30 patients in clinical sites across the U.S. The primary objective of this clinical trial is to select the dose(s) of NCX 4251 to advance into the next stage of developmentwhich will be a larger phase 2b clinical trial.
“There is no product approved in the United States solely for the treatment of blepharitis,” Tomas Navratil, PhD, Executive Vice President, Head of Development of Nicox, said in a company news release. “We believe that the combination of a potent corticosteroid in our novel nanocrystal suspension together with application directly to the site of inflammation, where the disease originates, could lead to an efficacious and better tolerated product for the treatment of blepharitis.”
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said, “Starting this second clinical program for the company, following the initiation of the NCX 470 clinical trial for the reduction of intraocular pressure in August last year, is a great achievement for our development team. With two commercial assets, two mid-stage clinical assets, and two innovative research projects we are continuing to deliver on building a unique, fully-integrated company in the ophthalmology space.”
This phase 2 trial was initiated following the FDA acceptance of the investigational new drug (IND) application submitted in December 2018, ahead of the previously disclosed target date of the first quarter of 2019.