RegeneRx Partner Updates on ARISE-3 Clinical Trial

ROCKVILLE, Md., Sept. 30, 2019 /PRNewswire/ -- 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 GtreeBNT, its Korean partner in the U.S. development of RGN-259 for the treatment of dry eye disease, issued an update on the U.S. phase 3 clinical trial.  The following translation was provided to RegeneRx by GtreeBNT, with certain clarifications made by RegeneRx:

"The ongoing clinical trial of dry eye (ARISE-3) is progressing smoothly according to the plan. In the second and third quarters of 2019, we made significant effort to select appropriate clinical study sites, and we have identified and selected around 15 eye hospitals as study sites and started clinical trials sequentially. In addition, by actively utilizing databases held by hospitals to select patients that meet the criteria for recruiting clinicians, and by proactively asking questions to better identify patient status learned from ARISE-1 and ARISE-2, we are becoming  more efficient and accurate with patient screening in this ARISE-3 clinical trial. In addition, since we are focusing more fully on clinical management based on know-how that we have learned from the two previous clinical trials, we expect that we will be able to control the risk of clinical trial failure. Furthermore, in the FDA approval process for new dry eye products, we believe that all data from previous trials as well as this ongoing study will be analyzed and included in the Data Totality concept. When you combine the results of two already completed clinical studies and the data from the currently ongoing ARISE-3 clinical trial, it is expected that all three Phase 3 studies will show the same consistent effect and trend. We also expect the pace of patient recruitment will be accelerated in the fall and winter, when the dry eye season comes, so we believe it will be easier to achieve our goal of completing the treatment of patients by the end of 2nd quarter of 2020. In the future, we will be able to talk more often about our ARISE-3 situations in order to address the interests of shareholders and related parties."

"We are very pleased that ARISE-3 is enrolling patients on schedule and that the anticipated completion of the trial by the end of Q2 2020 remains on target.  Completion of ARISE-3 will hit a major milestone for us and our partner, which we believe, if successful, should significantly enhance the value of RegeneRx.  As mentioned previously in communications with our stockholders and investors, Novartis recently purchased the dry eye drug, Xiidra^®, from Takeda, which had 2018 U.S. sales of approximately $400 million, for up to $5.3 billion.  We believe this indicates the value of the rapidly expanding market for approved dry eye drugs and is a benchmark for the potential future value of RGN-259.  We also believe RGN-259 is significantly differentiated from Xiidra^® and Restasis^®, the two FDA-approved drugs for dry eye, as RGN-259 has shown no significant toxicities or patient discomfort in over 1,000 patients treated to date and acts more rapidly to alleviate the signs and symptoms of dry eye," stated J.J. Finkelstein, president and chief executive officer.    

Dry eye syndrome is a common multi-factorial 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.

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.  RGN-259, the Company's ophthalmic eye drop, is currently in Phase 3 clinical trials for dry eye syndrome and neurotrophic keratopathy in the U.S.

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

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Any statements in this shareholder letter 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. Forward-looking statements in this shareholder letter include, but are not limited to, competitive products, statements regarding our strategic and research partnerships, status of clinical trials, regulatory applications and approvals, the development and value of our drug candidates, and the use of our drug candidates to treat various conditions. All forward-looking statements are expectations and estimates based upon information obtained and calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any clinical trial will be successful or confirm previous clinical results. 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, 2018, 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 shareholder letter 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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