RegeneRx Partner Submits Phase 3 Protocol for Neurotrophic Keratopathy (NK)

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First of Two Phase 3 NK Trials Expected to Start in November 2022

ROCKVILLE, Md., Sept. 27, 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), has announced that it submitted a protocol for its second phase 3 clinical trial (SEER-2) to the U.S. FDA on September 26th, evaluating RGN-259 as a treatment for neurotrophic keratopathy (NK).  NK is being developed by ReGenTree, a U.S. joint venture company between RegeneRx Biopharmaceuticals, Inc. and HLB Therapeutics.  The following is the text of HLB's press release with a few edits and modifications for clarification.

In July, HLB announced that it signed a contract with a global CRO to simultaneously conduct SEER-2 as the second phase 3 clinical trial in the U.S. and SEER-3 as the third phase 3 clinical trial in the U.S. and Europe to obtain an approval for NK treatment as soon as possible.

The clinical study design of SEER-2 and SEER-3 is based on the results of the first phase 3 clinical trial (SEER-1), where the number of subjects was relatively small, but good results were obtained. In the SEER-2 and SEER-3 studies, approximately 70 patients will be recruited in each study to evaluate efficacy, in particular complete healing after 4 weeks treatment.

In the U.S., ReGenTree is seeking clinical trial sites by contacting more than 70 ophthalmic hospitals and clinics and aims to start its first site in November.

For the SEER-3 clinical trial, which will be conducted simultaneously in the U.S. and Europe, the study site selection process is ongoing by ReGenTree among 80 candidate sites in six European countries, and preparation of applications to be filed through CTIS (Clinical Trials Information System) is also underway.

NK is a degenerative disease that reduces the sensitivity of the cornea and in severe cases worsens to corneal perforation, and is a rare disease that occurs in about five per 10,000 people in the U.S.  So far, the only treatment approved is Italian pharma company, Dompé's Oxervate, a recombinant form of human nerve growth factor whose cost is extremely high for eight weeks of treatment.

The RGN-259 previously received an orphan drug designation for the treatment of NK from FDA, and a distinguished difference from many rare diseases is that the market is very significant. Due to the prevalence of NK patients who must be treated despite the high cost of drugs, the market is expected to be USD $324.0 million in 2027. One of our goals in SEER-2 and SEER-3 is to successfully complete treatment within four weeks.

The company [ReGenTree] plans to drastically shorten the development period of RGN-259 by conducting the two phase 3 clinical trials (SEER-2, SEER-3) in the U.S. and Europe simultaneously [rather than sequentially]. Therefore, HLB Therapeutics is focusing all of its capabilities to achieve the possibility of applying for FDA BLA application in 2025 as an ultimate goal in its NK project.

About RGN-259

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. Thymosin beta 4, the active pharmaceutical ingredient of RGN-259, that has demonstrated various mechanisms of action, including promotion of cell migration, cytoprotection, wound healing, and anti-inflammatory properties.

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, 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.