Nicox Outlines Plans to Progress NCX 4251 into Phase 2b Trial Following Positive Meeting with FDA
Nicox SA announced that it has held a Type C meeting with the 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 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,” Dr. Tomas Navratil, PhD, EVP & Head of R&D of the Nicox Group and General Manager of Nicox Ophthalmics, said in a company news release. “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.