RegeneRx Biopharmaceuticals, Inc. Announces Clinical Results of RGN-259 for the Treatment of Neurotrophic Keratitis to be Presented at 2021 American Ophthalmology Association Meeting
October 29, 2021 at 11:08 am EDT
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RegeneRx Biopharmaceuticals, Inc. announced that the results of the initial randomized, double-masked, placebo-controlled, phase 3 clinical trial of RGN-259 for the treatment of neurotrophic keratitis (SEER-1) will be presented at the 2021 American Ophthalmology Association meeting in New Orleans, LA on November 12-15. The results will be jointly presented by ReGenTree LLC, the Company's U.S. joint venture to develop RGN-259 for ophthalmic indications, and Ora Inc, the clinical trial's CRO. Due to slow patient recruitment, the trial was closed after 18 of 46 patients completed treatment. Six out of 10 patients in the RGN-259-treated group and 1 out of 8 patients in the placebo-treated group achieved complete corneal healing in 4 weeks. In terms of the primary endpoint, the "ratio of corneal wound healed patients after four weeks' administration", the statistical difference was slightly over 0.05 (p = 0.0656, Fisher's exact test), due to the limited number of patients in each group. When another statistical analysis method was used to analyze the same primary endpoint (Chi square test), there was statistical significance, p = 0.0400. In addition, in a pre-specified secondary endpoint evaluating corneal epithelial healing at day 43 (two weeks post-treatment) and the durability of RGN-259 treatment, there was a clear statistical difference using the Fisher's exact test, p = 0.0359. Several other efficacy parameters were either highly significant or strongly trending toward statistical significance in the RGN-259 group indicating the depth of patient response to RGN-259. The product candidate was deemed to be safe and well-tolerated. Neurotrophic keratitis (NK) is a rare ophthalmic disease that can lead to corneal perforation within a short period of time due to urgent and rapid corneal damage in the event of an outbreak. ReGenTree has been developing a new ophthalmic eye drop for NK treatment using Thymosin Beta 4 (T?4), the active pharmaceutical ingredient of RGN-259, the drug candidate under development. It was previously designated an orphan drug by the U.S. FDA.
RegeneRx Biopharmaceuticals, Inc. (RegeneRx) is a biopharmaceutical company. The RegeneRx is focused on the development of a therapeutic peptide Thymosin beta 4(Tb4) for tissue and organ protection, repair, and regeneration. RegeneRx operates in the development and marketing of Tb4, an amino acid peptide. Tb4 is a synthetic copy of a naturally occurring 43-amino acid peptid originally isolated from bovine thymus glands. The Company's product candidates in clinical development includes RGN-259, RGN-352, and RGN-137. The Company's RGN -259 is a preservative-free topical eye drop for regeneration of corneal tissues damaged by injury, disease or other pathology. RGN-352 is an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases. Its RGN-137 is a topical gel for dermal wounds and reduction of scar tissue.
RegeneRx Biopharmaceuticals, Inc. Announces Clinical Results of RGN-259 for the Treatment of Neurotrophic Keratitis to be Presented at 2021 American Ophthalmology Association Meeting