Posted on Friday, April 23, 2021
Nicox, an international ophthalmology company, has announced that 102 patients out of a target of 200 have been randomized to the Phase 2b Mississippi clinical study for NCX 4251 in blepharitis. The first results are currently expected in the fourth quarter of 2021, on schedule.
Dr José Boyer, Interim Head of R&D of Nicox, said: “This step of recruiting 50% of patients in this phase 2b study for NCX 4251 in blepharitis is important because it allows to anticipate that the first results could be available by the end of the year, depending on the schedule. Our collaboration with one of the leaders in clinical research in the field of ophthalmology as well as the expertise of clinical investigators in blepharitis studies have enabled us to reach this stage despite the context linked to the pandemic of COVID-19. The encouraging results of the previous phase 2 Danube study give us hope that the potential of NCX 4251 in blepharitis will be demonstrated with this larger study and thus pave the way for the last phase of development of this drug candidate as an innovative treatment for the disease. blepharitis, a disease for which there is an unmet medical need. ”
NCX 4251 is an innovative and patented ophthalmic suspension of fluticasone propionate nanocrystals. Direct administration of NCX 4251 to the eyelids is designed to target the focus of inflammation while minimizing intraocular exposure to the steroid, fluticasone, and thus the risk of developing increased intraocular pressure and cataracts. The Mississippi Study is a Phase 2b clinical study to evaluate the 0.1% once-daily dose of NCX 4251, compared to placebo, in patients with acute episodes of blepharitis. 200 patients are expected to be randomized to clinical sites in the United States.
The primary endpoint is the proportion of patients achieving complete healing of eyelid redness, eyelid debris and eyelid discomfort by day 15, characteristic signs and symptoms of blepharitis. If NCX 4251 meets the primary efficacy endpoint for blepharitis, the Mississippi study could be the first of two pivotal studies required for a marketing authorization application in the United States for the treatment of acute episodes of blepharitis.
The Company continues to closely monitor the consequences of the COVID-19 outbreak and will notify the market of any delays.
Source: Nicox
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