RegeneRx Joint Venture Announces Efficacy Results of Neurotrophic Keratopathy Phase 3 Clinical Trial with RGN-259

ROCKVILLE, Md., May 14, 2020 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration announced efficacy results of its Phase 3 clinical trial in patients with neurotrophic keratopathy (NK). The full text of the press release, released through its U.S. joint venture, ReGenTree LLC., is included below:

PRINCETON, N.J. (May 14, 2020) – ReGenTree, LLC, a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc., (the Company) announced the results of a randomized, double masked, placebo-controlled Phase 3 clinical trial (SEER-1) using RGN-259 for the treatment of neurotrophic keratopathy (NK).

The study originally planned to recruit 46 patients using RGN-259, the same eye drop formulation used in the dry eye trials. However, because of slow patient recruitment and future pricing strategy for NK as a rare disease, the trial was closed early and 18 patients were analyzed. 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, "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, we also confirmed 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. 

"These results strongly demonstrated the efficacy of RGN-259 in NK, despite a very small number of patients. As expected, it was well tolerated and there were no safety issues associated with our drug," said a Company official.

During the past several years, the Company began developing a modified eye drop formulation that it believes will enhance the efficacy of thymosin beta 4 for NK, improve the patient experience, and allow a proprietary valued orphan product price for this rare disease. The Company has completed a preliminary formulation for NK patients that will be considered for use in future clinical study.

On April 30, 2020, the Company met with the FDA for a discussion about future development directions and received a positive assessment of Biologics License Application (BLA) readiness for non-clinical animal testing, manufacturing methods, and quality control. A discussion on clinical design and trial requirements for BLA approval was also reviewed.

NK is a corneal disease with decreased sensitivity of the cornea resulting in corneal degeneration that worsens to corneal perforation in severe cases leading to blindness. It is a rare disease that occurs in about 5 per 10,000 people in the US. So far, the only approved treatment to date is the Oxervate sold by Dompé Farmaceutici S.p.A., Italy. It is a recombinant protein drug comprising human nerve growth factor, which costs about $47,200 per month.

"Oxervate sales with extremely high-pricing have made global pharmaceutical companies interested in NK. We expect that the outcome in our NK trial will stimulate considerable interest in RGN-259 in the ophthalmology market space," stated an official from the Company.

About ReGenTree, LLC

ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc., specifically to develop RGN-259 in both the USA and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. Thus far, ReGenTree has completed two Phase 3 studies in the U.S. for dry eye which are ARISE-1 (Phase 2b/3) and ARISE-2 (Phase 3). Currently, the Company is conducting a third Phase 3 study (ARISE-3) for dry eye. In addition to dry eye, the Company is planning to conduct a Phase 3 study (SEER-2) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit www.regentreellc.com.

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. There can be no assurance that any current or future clinical trials will result in approved products or future value. There can also be no assurance that the Company will apply for a BLA in the future or that if the Company applies for a BLA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. 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.

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/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, is currently in Phase 3 clinical trials for dry eye syndrome and neurotrophic keratitis in the U.S.

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 press release include, but are not limited to, competitive products, statements from us or our joint venture regarding 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, 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.

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SOURCE RegeneRx Biopharmaceuticals, Inc.