RegeneRx Partner Updates on Phase 3 Dry Eye Trial

ROCKVILLE, Md., Feb. 3, 2020 /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. for development of RGN-259 for the treatment of dry eye disease, issued an update on the U.S. phase 3 clinical trial.  The following is a summary of a press release issued today by GtreeBNT:

GtreeBNT announced today that the third phase 3 clinical study [ARISE-3] of RGN-259 [a sterile, preservative-free eye drop], a new drug candidate for the treatment of dry eye syndrome under development by ReGenTree, LLC, a U.S. joint venture company between GtreeBNT and RegeneRx Biopharmaceuticals, is progressing well and without delay.  To date, over 350 dry eye patients have been entered into the study.

ARISE-3 will enroll over 700 eye dry patients at 19 eye clinics across the U.S. for two weeks of treatment, comparing the safety and efficacy of RGN-259 against placebo.

ReGenTree completed ARISE-1 in 2016 and ARISE-2 in 2017, which were also U.S. phase 3 studies, enrolling 317 and 601 patients with dry eye, respectively.  ReGenTree will consider the possibility of applying for a U.S. NDA based on the degree of statistical significance of dry eye sign and symptom improvement of RGN-259 over placebo.  ReGenTree believes that its clinical trials are the most advanced among those products currently undergoing clinical trials in the U.S.

Dry Eye syndrome is a multi-factorial disease-causing pain, itching, and congestion due to continual damage in the tear film. The global dry eye prescription market size amounts to approximately $3.0 billion, and the market is growing rapidly due to its high prevalence in industrial and densely populated urban regions, but there are only two compounds currently approved for treatment: Restasis by Allergan and Xiidra by Novartis.  Because it is believed that ReGenTree's RGN-259 will have a competitive edge over Restasis® and Xiidra®, GlobalData, one of the world's most prestigious pharmaceutical market analysts, announced in its Dry Eye Report published in 2018 that ReGenTree's RGN-259 would rank the first in sales of over $1 billion by 2026.

"We are very pleased that ARISE-3 is enrolling patients on schedule and we eagerly anticipate completion of the phase 3 trial this summer.  Completion of ARISE-3 will be a major milestone for us, which we believe, if successful, will significantly enhance the value of RegeneRx.  Moreover, we also look forward to the data read-out in the next few months from our other phase 3 clinical trial in patients with chronic neurotrophic keratitis, a highly debilitating lesion in the cornea," stated J.J. Finkelstein, president and 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, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, 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 keratitis in the U.S.

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

Forward Looking Statements

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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