RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced a clinical trial update provided by GtreeBNT, RegeneRx’s partner for development of RGN-259 and RGN-137 in the U.S.:

DRY EYE SYNDROME

“Regarding progress on ARISE-3, the manufacturing of the investigational product for ARISE-3 has been completed and the protocol for the study has been finalized and is now ready for the study. Also, since funding for the ARISE-3 clinical study is progressing smoothly towards the final stage, we will do our best to inform you of ARISE-3 study initiation as soon as possible. We also hope that our potential discussions with multinational pharmaceutical companies for a deal will accelerate the process by launching the ARISE-3 clinical trial.”

ARISE-3 is the designation for the phase 3 clinical trial for RGN-259, RegeneRx’s sterile, preservative-free, eyedrop to treat dry eye syndrome and other corneal wound disorders.

EPIDERMOLYSIS BULLOSA

“The production of investigational product for an Open Study has been completed. We also have a signed a contract with the clinical sites where recruitment of EB patients will start soon. In terms of the regulatory aspect, the FDA already approved our Open Study Protocol. We are currently preparing for the final clinical trial with the goal of FPFV (first patient first visit) to occur in November 2018. In June of this year, the U.S. FDA has announced new guidelines solely for EB, and our company is currently revising our study design for Phase 3 in accordance with the new FDA guidelines. The company is preparing to enter the clinical trial phase 3 in 2019. Our Open Study which is starting now is expected to make a decisive contribution to setting up a strategic clinical phase 3 study incorporating the new U.S. FDA guidelines.”

The EB clinical trial is to test RGN-137, RegeneRx’s dermal gel for wound healing in epidermolysis bullosa patients.  EB is an orphan disease in the U.S. and EU.

According to Gtree, “In summary the company is committed to providing important news for each pipeline under development, noting that the current progress is not far from the development progress plan, and moving toward a well-planned goal.”

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.  Plans for a third Phase 3 trial (ARISE-3) have been finalized although no start date has been set as of this date.  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 Asia through 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 and is expected to initiate an open study in November 2018.

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