RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced today that ReGenTree, LLC, a joint venture between GtreeBNT and RegeneRx, has executed an agreement with Ora, Inc., located in Andover, Massachusetts, for initiation of ARISE-3 to study ReGenTree’s new drug, RGN-259, a sterile, preservative-free eye drop for the treatment of dry eye syndrome. ARISE-3 is a randomized double-masked, placebo-controlled phase 3 clinical trial that is based on the results of previous clinical trials, ARISE-1 and ARISE-2.

According to ReGenTree officials, “A total of 700 patients will be enrolled in the trial and we expect the treatment will be completed in the first half of 2020.”

“We are pleased that ReGenTree has initiated ARISE-3 and look forward to moving RGN-259 through the FDA regulatory process, via ReGenTree or a partner, and into the market as soon as possible to treat this common disorder,” stated J.J. Finkelstein, Chief Executive Officer.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.

RegeneRx, through its U.S. joint venture, ReGenTree LLC, completed patient enrollment and treatment in its second Phase 3 clinical trial (ARISE-2) in approximately 600 patients with dry eye syndrome and reported positive clinical results with no safety issues.  ReGenTree is also conducting a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK).  Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asiathrough RegeneRx’s two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.

RGN-352, the Company’s Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke.  It may also have applications in patients with severe septic shock.

RGN-137, also designated an orphan drug in the U.S., is the Company’s Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition. The Company’s licensee, GtreeBNT, is sponsoring a clinical trials in the U.S. and Europe.

For additional information about RegeneRx please visit www.regenerx.com.