RegeneRx Biopharmaceuticals announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Thymosin beta 4 (Tβ4) for use in the treatment of dry eye syndrome. Tβ4 is the active pharmaceutical ingredient in RegeneRx's proprietary drug candidate, RGN-259, a first-in-class product candidate designed for topical administration to patients suffering from dry eye syndrome.
Dry eye syndrome is a multifactorial disease of the eye and its treatment with Tβ4 would represent a major step forward from current treatment options by promoting cell migration and proliferation, reducing inflammation and accelerating corneal epithelial growth.
RegeneRx's second Phase 3 dry eye trial (ARISE-2) is being sponsored by the company's U.S. joint venture, ReGenTree LLC, and was completed in July 2017 in approximately 600 dry eye patients in an effort to reproduce the clinically significant results seen in ARISE-1. Patient data are expected to be released by the fourth quarter of 2017.
"This patent is very significant in that it is specifically focused on the use of RGN-259 for the treatment of dry eye syndrome in the U.S., thus, enhancing our proprietary position with respect to this product candidate," J.J. Finkelstein, RegeneRx's president and chief executive officer said. "Our team has been working for a number of years to secure this piece of our intellectual property and is pleased to have been notified of the allowance by the USPTO."