Nicox’s Completes Pre-Defined Enrollment of NCX 4251 Mississippi Phase 2b Blepharitis Trial
June 1, 2021
Over 200 patients randomized
Top-line results expected in September 2021
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced that as of today, more than 200 patients, the pre-defined target, have been randomized in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial. Top-line results are expected to be announced during September 2021.
“Blepharitis is a highly prevalent eye condition with frequent exacerbation of signs and symptoms suffered by millions of patients, and there remains a significant unmet need for an effective treatment,” said Dr. José Boyer, Interim Head of R&D at Nicox, “The successful completion of the Mississippi trial enrollment on time in the current pandemic environment is testament to the strength and dedication of our clinical team, investigators and the Clinical Research Organization managing the trial. We look forward to announcing the results, which will drive the preparation of the next steps in the development of this novel asset, in a few months’ time.”
NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. The direct administration of NCX 4251 to the eyelids is designed to target the site of the inflammation whilst minimizing the intraocular exposure to the steroid fluticasone thereby reducing the risk of adverse effects such as increased intraocular pressure and cataract.
Mississippi is 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.
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. Should NCX 4251 meet this primary efficacy endpoint for blepharitis, the Mississippi trial could represent the first of two pivotal trials needed to support an NDA in the U.S. for the treatment of acute exacerbations of blepharitis.