Clinical Results of RGN-259 for the Treatment of Neurotrophic Keratitis to be Presented at 2021 American Ophthalmology Association Meeting

ROCKVILLE, Md., Oct. 29, 2021 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration), today announced that the results of the initial randomized, double-masked, placebo-controlled, phase 3 clinical trial of RGN-259 for the treatment of neurotrophic keratitis (SEER-1) will be presented at the 2021 American Ophthalmology Association meeting in New Orleans, LA on November 12-15.  The results will be jointly presented by ReGenTree LLC, the Company's U.S. joint venture to develop RGN-259 for ophthalmic indications, and Ora Inc, the clinical trial's CRO.

Due to slow patient recruitment, the trial was closed after 18 of 46 patients completed treatment. Six out of 10 patients in the RGN-259-treated group and 1 out of 8 patients in the placebo-treated group achieved complete corneal healing in 4 weeks. In terms of the primary endpoint, the "ratio of corneal wound healed patients after four weeks' administration", the statistical difference was slightly over 0.05 (p = 0.0656, Fisher's exact test), due to the limited number of patients in each group. When another statistical analysis method was used to analyze the same primary endpoint (Chi square test), there was statistical significance, p = 0.0400.

In addition, in a pre-specified secondary endpoint evaluating corneal epithelial healing at day 43 (two weeks post-treatment) and the durability of RGN-259 treatment, there was a clear statistical difference using the Fisher's exact test, p = 0.0359. Several other efficacy parameters were either highly significant or strongly trending toward statistical significance in the RGN-259 group indicating the depth of patient response to RGN-259.   The product candidate was deemed to be safe and well-tolerated.

Neurotrophic keratitis (NK) is a rare ophthalmic disease that can lead to corneal perforation within a short period of time due to urgent and rapid corneal damage in the event of an outbreak. ReGenTree has been developing a new ophthalmic eye drop for NK treatment using Thymosin Beta 4 (Tβ4), the active pharmaceutical ingredient of RGN-259, the drug candidate under development. It was previously designated an orphan drug by the U.S. FDA.

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/neuro 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.

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 statements from us 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, 2020, 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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