Nicox Initiates Phase 2b Trial of NCX 4251, a Potential First-in-Class Treatment for Blepharitis

Nicox SA announced the initiation of the Mississippi trial, a phase 2b clinical trial of NCX 4251, evaluating once-daily dosed NCX 4251 0.1% versus placebo in patients with acute exacerbations of blepharitis. NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. The direct application of NCX 4251 to the eyelids is designed to target the site of the inflammation whilst minimizing the intraocular exposure to the steroid fluticasone and the risk of developing increased IOP and cataract. The first patient in the Mississippi trial was enrolled in the U.S. on December 14, 2020.

“As agreed previously with the U.S. Food and Drug Administration, should NCX 4251 meet the primary efficacy endpoint for blepharitis, the Mississippi trial could represent the first of two pivotal trials needed to support a new drug application for the treatment of blepharitis in the US,” Dr. José Boyer, Vice President and Interim Head of R&D at Nicox, said in a company news release. “The Mississippi trial is also designed to assess the impact of NCX 4251 on dry eye disease, paving the way for a potential future standalone phase 3 program in this indication”.

The Mississippi trial is expected to randomize 200 patients at 5 to 10 clinical sites across the U.S. The primary outcome measure is the proportion of patients achieving complete cure in eyelid redness, eyelid debris and eyelid discomfort, the hallmark signs and symptoms of blepharitis, at Day 15. Secondary outcome measures also include signs and symptoms of dry eye disease. Topline results of the Mississippi trial are currently expected in Q4 2021.

The safety and tolerability of NCX 4251 ophthalmic suspension 0.1% were evaluated in the Danube phase 2 clinical trial, completed in late 2019. Nicox believes this is the first time that fluticasone propionate is being developed for an ophthalmic indication, and that NCX 4251 is the first product candidate developed as a targeted topical treatment of the eyelid for patients with acute exacerbations of blepharitis. Nicox estimates the market potential for treatment of acute exacerbations of blepharitis in the U.S., where there are currently no approved treatments, at more than $700 million annually, and expects it to reach over $1 billion by 2024.