ROCKVILLE, Md.—RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration, reported today that its U.S. joint venture partner and Pan Asian licensee, GtreeBNT, has been granted a new U.S. patent for a method of preventing or treating dry eye syndrome by administering thymosin beta 4 (Tβ4) with non-active ingredients to provide improved pharmacodynamics. Tβ4 is the active component of RGN-259, currently in separate Phase 3 clinical trials for dry eye syndrome and neurotrophic keratitis. The expiry of this new patent will be in 2035.
“We are pleased that Gtree has been granted another patent related to Tβ4 in the ophthalmic field emanating from its comprehensive development of RGN-259, our sterile, preservative-free eye drop solution. New intellectual property, such as patents and know-how developed under our licenses to Gtree and our U.S. joint venture, ReGenTree LLC, expands and extends the IP portfolio underlying these licenses,” said J.J. Finkelstein, president and chief executive officer of RegeneRx.
Dry eye syndrome (DES) is a common condition affecting millions of people throughout the world. DES is a multi-factorial 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. RGN-259 eye drops are safe and well-tolerated by patients, and in both ARISE-1 and ARISE-2 clinical trials patients reported minimal ocular discomfort, similar to that of the placebo.
RegeneRx also announced this week that the first patient has been enrolled in ARISE-3, a Phase 3 clinical trial sponsored by ReGenTree LLC, a U.S. joint venture between RegeneRx and GtreeBNT. The clinical trial will evaluate RGN-259 in 700 patients with dry eye syndrome at approximately fifteen nationwide clinical sites across the U.S., including hospitals and clinics specializing in ophthalmology, comparing the drug candidate to placebo. Completion is expected during mid-2020.
“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,” stated Finkelstein. “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.”