ROCKVILLE, Md., Sept. 30, 2016 /PRNewswire/ — RegeneRx Biopharmaceuticals, Inc. (RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced today that ReGenTree, RegeneRx’s U.S. joint venture with GtreeBNT, initiated its second Phase 3 trial for Dry Eye Syndrome this month and will begin patient enrollment shortly. The double-masked, placebo-controlled trial is expected to enroll approximately 500 patients who will be treated for 28 days with RGN-259, the Company’s proprietary, preservative-free eye drops. The clinical trial is expected to be completed during the second half of 2017 with the results expected to be reported during that period as well.
The trial’s primary endpoints are intended to replicate and confirm results from ReGenTree’s previous Phase 2b/3 trial showing, (1) a statistically significant improvement in inferior corneal staining and (2) a statistically significant improvement in ocular discomfort, when subjects are challenged in a controlled adverse environment (CAE™) at the end of treatment. The FDA has reviewed and agreed to the study protocol and overall clinical plan for RGN-259 for the treatment of Dry Eye Syndrome.
Previous clinical trials have shown that RGN-259 is safe and well-tolerated and without any side effects observed with other dry eye modalities.
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 Tβ4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome. The dry eye trial results were announced in May 2016 and ReGenTree has subsequently received permission from the U.S. FDA to proceed with its second Phase 3 trial. The Company is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx’s two Asian partnerships. RGN-352, the Company’s Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue damage associated disorders such as multiple sclerosis and traumatic injuries such as stroke. For additional information about RegeneRx please visitwww.regenerx.com.
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 or that projected dates for any regulatory filings with, or approvals by, the FDA or other government agencies will meet our or our partners’ estimated timelines. 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, 2015, 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.