Nicox Announces Last Patient Completed NCX 4251 Mississippi Phase 2b Blepharitis Trial

July 2, 2021

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced that the last patient in the NCX 4251 Mississippi Phase 2b blepharitis clinical trial has now completed the two-week treatment phase as well as the required two-week follow up period.  Top-line results are expected to be announced in September 2021.

“The Phase 2b Mississippi trial is designed to further explore the NCX 4251 product profile following the encouraging results of the Phase 2 Danube trial,” said Dr. José Boyer, Interim Head of R&D at Nicox, “The Mississippi trial includes a number of clinical endpoints related to signs and symptoms of blepharitis and dry eye disease.  We will therefore generate a significant amount of data which will be used to guide the future development of NCX 4251.  We will announce the next steps in the development of NCX 4251 following an End-of-Phase 2 meeting with the FDA.”

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, and has recruited over 200 patients.  The primary outcome measure is the proportion of patients achieving at Day 15 complete cure in eyelid redness, eyelid debris and eyelid discomfort, the hallmark signs and symptoms of blepharitis.

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