First Patient Enrolled in RegeneRx JV Phase 3 Dry Eye Trial

RegeneRx Biopharmaceuticals announced the first patient has been enrolled in ARISE-3, a phase 3 clinical trial sponsored by ReGenTree, a U.S. joint venture between RegeneRx and GtreeBNT, a Korean biopharmaceutical company. The clinical trial will evaluate RGN-259, a sterile, preservative-free eye drop in 700 patients with dry eye syndrome (DES) at approximately fifteen nationwide clinical sites across the U.S., including hospitals and clinics specializing in ophthalmology, comparing the drug candidate to placebo.

"We are very pleased that ARISE-3 has begun enrolling patients. This is a critical trial for us and our partner, which we believe, if successful, should significantly enhance the value of RegeneRx. To that end, the Novartis purchase of Xiidra for up to $5.4 billion indicates the value of the rapidly growing market for FDA-approved dry eye drugs and is a benchmark for the potential future value of RGN-259 eye drops for DES. We believe RGN-259 is significantly differentiated from Xiidra and Restasis, the two FDA-approved drugs used for dry eye, as RGN-259 has shown no toxicities or patient discomfort in the hundreds of patients treated to date and appears to act more rapidly to reduce inflammation and alleviate the signs and symptoms of dry eye," said J.J. Finkelstein, president and chief executive officer.

Dry eye syndrome is a common condition affecting millions of people throughout the world. DES is a disorder where loss of homeostasis of the tear film results in pain, itching, blurry vision, and dryness, among other symptoms. RGN-259 eye drops contain an active small protein, thymosin beta 4, which is naturally occurring in tears and other body fluids. RGN-259 eye drops have demonstrated wide-ranging and multifunctional activities. Such activities underlie the efficacy of RGN-259 eye drops seen to date in alleviating both the signs and symptoms of dry eye. Moreover, RGN-259 eye drops are safe and well-tolerated by patients, and in both ARISE-1 and ARISE-2, patients reported minimal ocular discomfort similar to that of the placebo.