Nicox Does Not Meet Primary or Secondary Endpoints in Phase 2b Mississippi Blepharitis Trial

Nicox SA announced the results from its Mississippi phase 2b clinical trial evaluating once-daily dosed NCX 4251, fluticasone propionate ophthalmic suspension 0.1%, against placebo in patients with acute exacerbations of blepharitis. The primary outcome measure was the proportion of patients achieving complete cure in all three hallmark signs and symptoms of blepharitis, eyelid redness, eyelid debris, and eyelid discomfort, at Day 15, with two secondary outcome measures on signs and symptoms of dry eye. 

The trial did not meet the primary or secondary efficacy endpoints. However, a signal of NCX 4251’s potential efficacy was seen in the trial with NCX 4251 0.1% showing a numerical improvement over placebo in the primary outcome measure of complete cure in eyelid redness, eyelid debris, and eyelid discomfort at Day 15. NCX 4251 also showed a statistically significant difference against placebo in the exploratory endpoint of change from baseline in the composite score of the same key signs and symptoms at Day 8 (P=0.03), Day 11 (P=0.01) and Day 15 (P=0.01).

Data analysis is continuing in order to decide on the key signs and symptoms of focus for future development.

NCX 4251 was found to be safe and well-tolerated over 14 days’ treatment, with no serious adverse events, and all of the adverse events for the NCX 4251 treatment arm were mild. There were no discontinuations in the study due to an adverse event.

“We are pleased to see that there is a signal of efficacy in the composite score of the signs and symptoms of blepharitis. We will continue to analyze the significant amount of data from the trial with the goal of discussing the future development plan in a meeting with the United States Food and Drug Administration early next year. We would like to thank all the patients, clinical sites and clinical investigators who participated in the Mississippi trial," Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in a company news release.

Mississippi was a phase 2b clinical trial, which recruited 224 patients at multiple clinical centers in the U.S., evaluating once-daily dosed NCX 4251, fluticasone propionate ophthalmic suspension 0.1%, versus placebo in patients with acute exacerbations of blepharitis. The next steps and timelines in the development of NCX 4251 will be announced following a meeting with the FDA expected to take place at the beginning of 2022.