RegeneRx JV Locks Clinical Trial Database for Phase 3 Dry Eye Trial

ROCKVILLE, Md., Feb. 24, 2021 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage biopharmaceutical company focused on tissue protection, repair and regeneration, announced that the ARISE-3 Phase 3 clinical trial database evaluating RGN-259 eyedrops for the treatment of dry eye syndrome has been locked after collecting and verifying patient data from 20 U.S. clinical sites participating in the study.  Database lock is a specific time point prior to unmasking the trial and after which no patient information may be modified.

ReGenTree LLC, the U.S. joint venture company owned by RegeneRx Biopharmaceuticals, Inc. and GtreeBNT, a Korean biopharmaceutical company, is sponsoring the clinical trial and will unmask the study and begin the biostatistical analysis that will include not only primary endpoints, but also other pre-specified endpoints identified in the clinical protocol. 

GtreeBNT has previously stated that it has secured major intellectual property rights, including patents related to composition, formulation, and manufacturing process for RGN-259 eye drops.  Last year RGN-259, a 43 amino acid peptide, was reclassified from a new chemical entity to a biologic by the FDA.  Thus, it will require a Biologics License Application (BLA), rather than a New Drug Application (NDA) for marketing approval and receive 12 years of market exclusivity in the U.S. if the product is approved by the FDA.

GlobalData, a well-known market research publisher worldwide, estimated that the dry eye market will reach $11.1 billion in 2028 in 9 major countries including the U.S. according to its market research report published in May 2020. Also, GlobalData expects that due to RGN-259's unique mechanism of action (MOA), it would garner significant market share during the forecast period after its market launch.

"We are pleased that the ARISE-3 database is locked and undergoing statistical analysis.  Topline results will be released soon and, hopefully, we will see a positive outcome in this very important clinical trial," stated J.J. Finkelstein, RegeneRx president and chief executive.

About RegeneRx Biopharmaceuticals, Inc.

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/TBI 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, recently complete a phase 3 clinical trial for dry eye syndrome in the U.S. and is expected to report top line results for the ARISE-3 clinical trial in early 2021.

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. Forward-looking statements in this press release include, but are not limited to, competitive products, statements from us or our U.S. joint venture, or derived from independent market research reports regarding strategic and research partnerships, status of clinical trials, reclassification of our drug candidates from drugs to biologics, 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/or calculated by the Company or its joint venture partner 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, 2019, 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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