Pegfilgrastim(Dompe Biotec SpA)

ROCKVILLE, Md., July 18, 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 signed a letter of intent with a global ophthalmology contract research organization (CRO) to conduct two phase 3 clinical trials simultaneously beginning in the Fall 2022 in the U.S. and Europe for patients with neurotrophic keratitis (NK). The FDA requires two successful phase 3 trials in most circumstances prior to submitting a new drug or biologics application (NDA/BLA). The purpose of conducting simultaneous trials is to reduce the time required to complete phase 3. "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, HLBT decided to conduct two clinical trials for NK at the same time because it is expected that RGN-259 would have a high possibility of success in this disease. Unlike dry eye disease, clinical studies for neurotrophic keratitis require a very simple and clear single primary endpoint, such as complete healing," according to HLBT. Currently, Oxervate, developed by Dompé, is the only available treatment for NK in the United States. However, the cost for Oxervate is very expensive, approaching $50,000 per month. The CRO, which signed the letter of intent with ReGenTree, a U.S. joint venture between RegeneRx and HLBT, participated in the clinical trial of Oxervate and has clinical experience and expertise in NK clinical trials. Neurotrophic Keratitis is a relatively large market for rare diseases as about 20,000 patients contract this disease annually in the United States. In October 2022, ReGenTree plans to apply to the FDA for a Special Protocol Assessment (SPA) for an additional dry eye trial (ARISE-4). The SPA program allows FDA specialists to provide input and collaborate with a sponsor (ReGenTree) in setting up clinical protocols and statistical analysis plans, which is binding. By participating together at this stage of the protocol development, the sponsor and FDA have a clear understanding of the requisite trial protocol. "We are pleased HLBT is continuing to move forward with both NK and DED clinical trials with RGN-259 as previously discussed. 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," stated J.J. Finkelstein, RegeneRx's 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/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. 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. Company Codes: OTC-QB:RGRX, OTC-PINK:RGRX, OTC-BB:RGRX