Nicox SA announced that NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, has met the primary objective of its U.S. multicenter, dose escalating, first-in-human, phase 2 clinical trial (referred to as ‘Danube’) evaluating the safety and tolerability of NCX 4251 in patients with acute exacerbations of blepharitis.
The primary objective of the Danube clinical trial was to select the dose(s) of NCX 4251 to advance into the next stage of development. NCX 4251 0.1% once daily (QD) treatment was selected to advance into a larger phase 2b clinical trial, pending the outcome of a meeting with the FDA in early 2020. Both once daily and twice daily (BID) NCX 4251 0.1% were well tolerated and there were no treatment related serious adverse events or adverse events of IOP elevation, the most common side effect of topical ophthalmic steroids.
The selected dose also demonstrated promising efficacy against exploratory endpoints in the study in reducing the signs and symptoms of dry eye disease.
“The delivery of these encouraging blepharitis results on time demonstrates that Nicox is executing on its R&D strategy to potentially have two advanced clinical programs in 2020,” Tomas Navratil, PhD, Executive Vice President, Head of Development of Nicox, said in a company news release. “We are also pleased by NCX 4251’s encouraging trends in the reduction of the signs and symptoms of dry eye disease, an important market in which NCX 4251 may have a benefit for treatment of the acute exacerbations of dry eye disease and as an induction therapy prior to the initiation of chronic dry eye treatment. We plan to discuss next steps for NCX 4251 with the U.S. FDA early next year and to secure the financial resources to accelerate its development.”
NCX 4251 Danube Phase 2 Trial Summary
- All patients in the once daily (n=10 for NCX 4251 and n=5 for placebo) and twice daily (n=10 for NCX 4251 and n=11 for placebo) cohorts successfully completed the 14-day dosing period followed by a 14-day safety evaluation period.
- There were no serious adverse events, no treatment related systemic adverse events, and no adverse events of IOP elevation, the most common side effect of topical ophthalmic steroids.
- Although the study was not powered for efficacy, in the prospectively defined pooled analysis of QD and BID dosing of NCX 4251 0.1%, there was a statistically significant reduction in the composite score of eyelid redness, eyelid debris and eyelid discomfort at the Day 14 study endpoint (n = 20 for NCX 4251 0.1% and n = 16 for placebo with p = 0.047 for study eyes and p = 0.025 for combined eyes and contralateral eyes).
- Exploratory analyses of signs and symptoms of dry eye disease, including symptom evaluation using visual analog scale and sign evaluation based on fluorescein staining, revealed encouraging reduction from pre-study baselines.
NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, which Nicox believes is the first product candidate developed as a targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. Blepharitis is a common eye condition characterized by eyelid inflammation.