Nicox Outlines Plans to Progress NCX 4251 into Phase 2b Trial Following Positive Meeting with FDA

April 8, 2020

Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, announced today that it has held a Type C meeting with the U.S. Food and Drug Administration (FDA) in which the data from the recently completed Danube Phase 2 clinical trial of NCX 4251 was reviewed and the next NCX 4251 trial designs were discussed. Given the positive Danube Phase 2 trial results in reduction of the signs and symptoms of both blepharitis and dry eye disease, an agreement was reached with the U.S. FDA for NCX 4251 Phase 2b trial designs in both acute exacerbations of blepharitis and the reduction of signs and symptoms of dry eye disease. NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, has the potential for development in blepharitis and in dry eye disease, and is Nicox’s second product candidate in clinical development.

Following our successful meeting with the FDA, we plan to conduct a Phase 2b efficacy and safety trial of NCX 4251 including both blepharitis and dry eye endpoints. Based on the FDA meeting outcome, Nicox has the option to declare either the blepharitis endpoint or dry eye endpoints as the primary efficacy outcome of this trial,” said Dr. Tomas Navratil, PhD, EVP & Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics, Inc. “Based on the positive outcome of the Danube clinical trial, we will continue the development with the 0.1% once a day dose of NCX 4251, and will announce the timing and further Phase 2b trial design details in due course.”

The Danube trial was a U.S. multicenter, double-masked, dose escalating, first-in-human, Phase 2 clinical trial which evaluated the safety and tolerability of NCX 4251 in patients with acute exacerbations of blepharitis. The primary objective of the Danube trial was to select the dose(s) of NCX 4251 to advance into the next stage of development. Both once daily (QD) and twice daily (BID) NCX 4251 0.1% were well tolerated and there were no treatment related serious adverse events nor adverse events of intraocular pressure elevation, the most common side effect of topical ophthalmic steroids. Although the trial was not powered for efficacy, prospectively defined pooled analysis of QD and BID NCX 4251 0.1% demonstrated statistically significant reduction in signs and symptoms of blepharitis (n=20 for NCX 4251 0.1% and n=16 for placebo). Based on these results, NCX 4251 0.1% QD treatment was selected to advance into a larger Phase 2b clinical trial. The selected dose also demonstrated promising efficacy against exploratory endpoints in the trial in reducing the signs and symptoms of dry eye disease. The timing of the future program for NCX 4251 is subject to securing the financial resources to advance its development.

About NCX 4251

NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals which is being developed as a targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. We believe that 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 margin for patients with acute exacerbations of blepharitis. Thus we believe that NCX 4251 may be able to achieve first-in-class status as a treatment for this indication. Blepharitis is a common eye condition characterized by eyelid inflammation. NCX 4251 is being developed for application via eyelid applicator to the eyelid margin, applied directly to the site where the disease originates and thereby potentially minimizing penetration of the drug through the cornea which can lead to the damaging side effects such as intraocular pressure (IOP) increase found with current topical steroids.

Fluticasone propionate, the active ingredient in NCX 4251, which has not previously been approved in a topical formulation for use in ophthalmology, has an affinity for the glucocorticoid receptor which is approximately ten times greater than dexamethasone, a corticosteroid commonly used in ophthalmology. Fluticasone is a glucocorticoid with potent anti inflammatory properties that has been approved in numerous drug products over the past 20 years for the treatment of various indications including dermatology, rhinitis and asthma.

Blepharitis – an untapped market

Blepharitis is a condition in which the margins of the eyelids become red and swollen and may contain dandruff like matter. Of patients seen by ophthalmologists and optometrists, 37% and 47%, respectively, present with signs of the disease. There is currently no FDA approved prescription product solely indicated for blepharitis, which limits our ability to estimate prevalence and market size. There are, however, antimicrobial and antibiotic products, such as ointments and eye drops, indicated for the treatment of blepharitis, as well as other conditions. Treatment options also include lid scrubs, topical ophthalmic steroids, topical ophthalmic antibiotics and topical ophthalmic antibiotic/steroid combinations. We estimate that the market for treatment of acute exacerbations of blepharitis in the U.S. alone may be more than $700 million, rising to over $1 billion by 2024.

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