ROCKVILLE, Md., Nov. 9, 2020 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration announced today that the final patient in its 700 subject, ARISE-3 phase 3 clinical trial for dry eye syndrome has completed treatment and follow-up. The ARISE-3 trial is being sponsored by ReGenTree, LLC, a U.S. joint venture company owned by RegeneRx and G-treeBNT, a Korean biopharmaceutical company.
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome. RGN-259 is a proprietary eye drop that, to date, has demonstrated fast onset efficacy in two previous phase 3 clinical trials, "ARISE-1" and "ARISE-2", is safe and well-tolerated, and has not shown any adverse side effects such as eye irritation, stinging, visual disturbance, etc., unlike currently approved products.
"We are pleased to report that the ARISE-3 trial has successfully completed treatment and follow-up of the last patient during a very challenging time created by the COVID-19 pandemic. Next steps are to lock the subject database and conduct the appropriate statistical analyses to determine the results of the trial," stated J.J. Finkelstein, president and chief executive.
This year, GtreeBNT announced that it has secured additional major intellectual property rights, including patents related to composition, formulation, and manufacturing of RGN-259 eye drops, and that RGN-259 has recently been reclassified as a biologic requiring a Biologics License Application (BLA), rather than an New Drug Application (NDA), conferring 12 years of market exclusivity when the product is approved by FDA.
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.
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, wound repair, and tissue 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 partner 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.
SOURCE RegeneRx Biopharmaceuticals, Inc.