RGN-259 (Tβ4) Improves Clinically Important Dry Eye Efficacies in Comparison with Prescription Drugs in Dry Eye Model

ROCKVILLE, Md., July 16, 2018 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that a new study was published comparing RGN-259 with currently approved prescription products for dry eye syndrome (DES).  In the study, researchers demonstrated that after ten days of treatment RGN-259 performed equal to or better than cyclosporine A (Restasis^®), lifitegrast (Xiidra^®), and diquafosol (Diquas^®).  The study parameters measured were tear production, corneal smoothness, and decreased fluorescein staining, among others.  Corneal epithelial detachment, conjunctival goblet cells, mucin production, and expression of inflammatory factors were also evaluated.  RGN-259 was equal to or better than the three other approved products in each case. In conclusion, the authors stated that, "RGN-259 promoted recovery of mucins and goblet cells, improved corneal integrity, and reduced inflammation in a dry eye mouse model and was equal to or more effective than prescription treatments."

The study was published on July 12, 2018, in the journal, Scientific Reports, an online open access scientific mega journal and part of the Nature Publishing Group.  The study was conducted by researchers who are either consultants to RegeneRx or, employees of, or consultants to GtreeBNT/ReGenTree LLC, a RegeneRx licensee for RGN-259 in North American and certain Asian territories.  Some of the study data were previously presented at the 2018 ARVO meeting in May 2018.

RGN-259 is currently in Phase 3 clinical trials in the U.S. and been studied in approximately 1,000 patients.  In addition to the reported rapid onset of clinical efficacies, RGN-259 has not reported any significant side effects compared to other products currently approved for DES.

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, recently completed patient enrollment and treatment in its second Phase 3 clinical trial in approximately 600 patients with dry eye syndrome, 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) targeted for completion in 2018.  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. 

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 phase 3 clinical trial in the U.S. and is expected to initiate the study in 2018.

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

About ReGenTree, LLC

ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259 in the U.S.A. and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. Thus far, ReGenTree has completed two Phase 3 studies in the U.S. for dry eye which are ARISE-1 (Phase 2/3) and ARISE-2 (Phase 3). In addition to dry eye, the company is currently conducting a Phase 3 study for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit www.regentreellc.com.

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any current or future animal studies or clinical trials will result in future value or approved products. There can also be no assurance that the Company will apply for an NDA in the future or that if the Company applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2017, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date.  The Company specifically disclaims any obligation to update this information as a result of future events or otherwise, except as required by applicable law.

SOURCE RegeneRx Biopharmaceuticals, Inc.

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