Nicox has provided certain regulatory and clinical updates for NCX 4251, its novel ophthalmic suspension of fluticasone propionate nanocrystals being developed for the first time as a topical treatment for acute exacerbation of blepharitis.
Based on feedback from a recent pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA), Nicox is finalizing the design of a first-in-human Phase 2 clinical trial evaluating the efficacy and safety of NCX 4251 versus a vehicle comparator in patients with acute exacerbation of blepharitis, said the company.
This multi-center, dose-ranging study will be conducted in the U.S.
The primary objective of the study is to demonstrate a statistically significant and clinically relevant difference in the proportion of subjects with clinical cure (defined as the absence of lid margin redness, lid debris, and lid discomfort) obtained with each dose of NCX 4251 versus vehicle. An additional objective of the study, the company said, is to identify the recommended Phase 3 dose of NCX 4251. Subject to IND filing and acceptance, Nicox plans to initiate this Phase 2 clinical trial during the fourth quarter of 2017 and expects the trial to take approximately 1 year to complete.
Dr. Mike Bergamini, EVP and Chief Scientific Officer of Nicox commented “Blepharitis is a significant unmet medical need in ophthalmology. Despite the high incidence of this uncomfortable condition, there are currently no FDA-approved products specifically designed to treat it, and patients often rely on simple, but frequently ineffective, cleansing techniques. Fluticasone, the active ingredient of NCX 4251, is the most potent steroid in development for ocular use, and we believe that our unique formulation will be able to provide relief to these patients. We are also pleased to be working with Ora, Inc., the world`s leading ophthalmic CRO, which has extensive experience in the development of ophthalmic products and proprietary research models that will help us conduct a scientifically robust clinical trial.”
“Looking ahead, we believe that 2017 will be a transformative year for Nicox” said Michele Garufi, Chairman and Chief Executive Officer of Nicox. “In addition to the progress of NCX 4251, we plan to communicate the timetable for entry into Phase 2 with NCX 470 for glaucoma within the first quarter. Of course, the main event of the year remains, as stated previously by Bausch + Lomb, the launch of latanoprostene bunod in the U.S, expected in mid-20171. For AC-170, we remain on track to provide an update on the re-submission timing of the NDA by February.”