Nicox Announces Plans for NCX 4251 Phase 2 Trial in Blepharitis
October 13, 2020
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Mississippi Phase 2 trial will evaluate once-daily dosed NCX 4251 0.1% against placebo in blepharitis patients
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Trial is targeted to start in December 2020 with top-line results expected in Q4 2021
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If the primary endpoint is met, the trial could count as one of two pivotal trials required for approval in the U.S.
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the upcoming Mississippi Phase 2 trial of its second clinical candidate, NCX 4251 0.1%, will be focused on acute exacerbations of blepharitis. If successful in meeting the primary endpoint for blepharitis previously agreed upon with the U.S. Food and Drug Administration (FDA), the trial could represent the first of two pivotal trials needed to support a New Drug Application (NDA) in the U.S. The Mississippi trial is targeted to start in December 2020 with top-line results currently expected in Q4 2021.
NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, was evaluated in the successful Danube Phase 2 trial completed in late 2019. While not powered for efficacy, in the prospectively defined pooled analysis of once-daily and twice-daily 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 day 14. Eyelid redness, eyelid debris and eyelid discomfort are the hallmark signs and symptoms of blepharitis.
“With a U.S. market for the treatment of acute exacerbations of blepharitis estimated at over $700 million, and no product approved for this indication, we believe that targeting blepharitis first is the best value-creating opportunity for Nicox.” said Dr José Boyer, Vice President and Head, Clinical Development at Nicox. “Our Danube Phase 2 trial demonstrated a robust efficacy of NCX 4251 in this indication and also showed promising efficacy in reducing signs and symptoms of dry eye disease. Consequently, we will also include signs and symptoms of dry eye disease as secondary efficacy endpoints in the forthcoming Mississippi trial, paving the way for a potential future additional standalone Phase 3 program in dry eye disease.”
Further details will be disclosed at the time of the start of the trial in December.
We continue to closely watch the spread of COVID-19 and its impact. We do not currently anticipate delays to our clinical timelines but we are monitoring the situation and will provide updates if there is an impact on our development projects and timelines.
NCX 4251 – Danube Phase 2 trial
NCX 4251 completed a U.S. multicenter, dose escalating, first-in-human, 36-patient Danube Phase 2 clinical trial which evaluated its safety and tolerability in patients with acute exacerbations of blepharitis. In the Danube Phase 2 trial, NCX 4251 met the primary objective of selecting the dose for further development. Although the trial was not powered for efficacy, in the prospectively defined pooled analysis of once-daily (QD) and twice-daily (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 study eyes and contralateral eyes). The NCX 4251 0.1% QD treatment was selected to advance into a larger Phase 2 clinical trial. The selected dose of NCX 4251 0.1%, also demonstrated promising efficacy in reducing signs and symptoms of dry eye disease. 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.
Following the Danube trial, a successful Type C meeting was held with the U.S. FDA, with agreement on Phase 2 trial designs for NCX 4251 in both acute exacerbations of blepharitis and the reduction of signs and symptoms of dry eye disease.