Publication of RGN-259 Phase 3 Clinical Trial Results in Patients with Neurotrophic Keratopathy
ROCKVILLE, Md., Jan. 3, 2023 /PRNewswire/ — RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX)(“RegeneRx” or “Company”), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, is reporting today a new scientific publication describing the safety and efficacy of RGN-259 eyedrops in a phase 3 clinical trial in patients with Neurotrophic Keratopathy (NK). The product candidate is being developed by ReGenTree, LLC, a U.S. joint venture between RegeneRx Biopharmaceuticals and HLB Therapeutics.
The study determined the efficacy and safety of RGN-259 in promoting the healing of persistent epithelial defects in patients with Stage 2 and Stage 3 NK. Complete healing occurred after 4 weeks in 6 of 10 RGN-259-treated subjects and 1 of 8 placebo-treated subjects, indicating a strong efficacy trend. Additional statistically significant healing was observed at day 43, two weeks after cessation of treatment, with no recurrent defects.
RGN-259-treated subjects had significant improvements at multiple time points in ocular discomfort, foreign body sensation, and dryness, which were not seen in the placebo group. No significant adverse effects were observed.
“While these results have been previously reported, it is important that the final data were published in a peer-reviewed scientific journal. Based on the results of this trial, we look forward to the first of two phase 3 trials in the U.S. and EU with the first patient expected to be entered later this month. The trials are being sponsored by our JV partner, ReGenTree,” stated Dr. Allan Goldstein, Chairman and Chief Scientific Officer of RegeneRx.
The publication is entitled, 0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial, Int. J. Mol. Sci. 2023, 24, 554; https://doi.org/10.3390/ijms24010554. The authors of the article are consultants to and/or joint venture partners of RegeneRx Biopharmaceuticals, Inc.
RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy. To date, over 1700 subjects have received RGN-259 indicating various degrees of efficacy in both DED and NK. RGN-259 has shown to be quick-acting, well-tolerated and does not have the documented side effects of other approved pharmaceutical products for these indications. Thymosin beta 4, is the active pharmaceutical ingredient of RGN-259 that has demonstrated various mechanisms of action, including promotion of cell migration, cytoprotection, wound healing, and anti-inflammatory properties.
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SOURCE RegeneRx Biopharmaceuticals, Inc.