RegeneRx Licensee to Expand Phase 3 Clinical Trial Program with RGN-259

ROCKVILLE, Md., June 22, 2022 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, is reporting today that its U.S. joint venture (JV) partner and licensee, HLB Therapeutics (HLBT), is planning to expand its ophthalmic clinical development program with RGN-259 in two indications, Neurotrophic Keratopathy (NK) and Dry Eye Disease (DED), beginning in November of 2022.  The trials will be sponsored by the U.S. JV, ReGenTree, LLC.

The following is information provided to RegeneRx by HLBT, with minor edits and insertion of bracketed clarifications by the Company:

According the HLBT, "Although we at ReGenTree had focused on dry eye clinical trials in recent years, we now plan to run both DED and NK clinical development program simultaneously. In the case of DED, for which ReGenTree conducted a pre-BLA meeting in February this year, we plan to apply for SPA (Special Protocol Assessment) to the FDA around this October.  SPA is a program in which FDA specialists provide a sponsor (ReGenTree) with collaboration in setting up clinical protocols and statistical analysis plans.  The agreed clinical trial design with FDA is binding and this program will give the sponsor and FDA a clear understanding [of relevant trial criteria] by participating together at this stage of the clinical trial protocol development."

"In addition, ReGenTree will start the two phase 3 trials for NK simultaneously [to meet the requirement of two independent phase 3 clinical trials necessary for FDA marketing approval]. ReGenTree will seek to confirm the efficacy observed in SEER-1 despite the very small number of subjects in that trial. Based on the results of the SEER-1 study, ReGenTree has developed a plan to enter into two phase 3 studies (SEER-2, SEER-3) simultaneously with 60 patients in each study. To this end, it plans to retain a contract research organization (CRO) very shortly and start recruitment of patients around this November."

"We are pleased HLBT is moving forward with both NK and DED clinical trials with RGN-259 as we believe our product candidate has significant potential as an important therapeutic modality for numerous ophthalmic disorders.  Accelerating NK clinical development by simultaneously conducting two trials will speed up the process while also working with the FDA under an SPA to refine our approach to DED. I believe this strategy indicates that HLBT is fully committed to RGN-259's clinical development in the field of ophthalmology," stated J.J. Finkelstein, RegeneRx's president and chief executive. 

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/neuro and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea and Japan, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.

RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.  To date, over 1700 subjects have received RGN-259 indicating various degrees of efficacy in both DED and NK.  RGN-259 has shown to be quick-acting, well-tolerated and does not have the documented side effects of other approved pharmaceutical products for these indications.

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 statements from us, our partners, or within research published by third parties. There can be no assurance that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view 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, 2021, 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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