A clinical-stage drug development company focused on tissue protection, repair and regeneration, announced today that the first patient has been enrolled in ARISE-3, a phase 3 clinical trial sponsored by ReGenTree LLC, a U.S. joint venture between RegeneRx and GtreeBNT, a Korean biopharmaceutical company. The clinical trial will evaluate RGN-259, a sterile, preservative-free eye drop in 700 patients with dry eye syndrome (DES) at approximately fifteen nationwide clinical sites across the U.S., including hospitals and clinics specializing in ophthalmology, comparing the drug candidate to placebo. Completion is expected during mid-2020. Additional information may be found at clinicaltrials.gov/ct2/show/NCT03937882?term=arise-3&rank=1.
"We are very pleased that ARISE-3 has begun enrolling patients. This is a critical trial for us and our partner, which we believe, if successful, should significantly enhance the value of RegeneRx. To that end, the Novartis purchase of Xiidra for up to $5.4 billion indicates the value of the rapidly growing market for FDA-approved dry eye drugs and is a benchmark for the potential future value of RGN-259 eye drops for DES. We believe RGN-259 is significantly differentiated from Xiidra and Restasis, the two FDA-approved drugs used for dry eye, as RGN-259 has shown no toxicities or patient discomfort in the hundreds of patients treated to date and appears to act more rapidly to reduce inflammation and alleviate the signs and symptoms of dry eye," stated J.J. Finkelstein, president and chief executive officer.
Dry eye syndrome is a common condition affecting millions of people throughout the world. DES is a disorder where loss of homeostasis of the tear film results in pain, itching, blurry vision, and dryness, among other symptoms. RGN-259 eye drops contain an active small protein, thymosin beta 4, which is naturally occurring in tears and other body fluids. RGN-259 eye drops have demonstrated wide-ranging and multifunctional activities. Such activities underlie the efficacy of RGN-259 eye drops seen to date in alleviating both the signs and symptoms of dry eye. Moreover, RGN-259 eye drops are safe and well-tolerated by patients, and in both ARISE-1 and ARISE-2, patients reported minimal ocular discomfort similar to that of the placebo.
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 and dermal indications, three active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), 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 keratopathy.
For additional information about RegeneRx please visit www.regenerx.com.
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 shareholder letter include, but are not limited to, competitive products, statements regarding our strategic and research partnerships, 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, 2018, 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.