ROCKVILLE, Md., Aug. 24, 2016 /PRNewswire/ — RegeneRx Biopharmaceuticals, Inc. (RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its U.S. joint venture, ReGenTree, LLC, has received permission from the U.S. FDA to proceed with a second Phase 3 clinical trial using RGN-259 to treat patients with dry eye syndrome (DES).
ReGenTree, LLC, a joint venture company between RegeneRx and GtreeBNT, a Korean Biopharmaceutical Company, officially received a confirmatory response from the FDA for its second Phase 3 protocol and overall development plan of RGN-259, a new drug candidate to treat dry eye syndrome (DES).
ReGenTree plans to initiate the second Phase 3 trial during the 3rd quarter of this year based on the positive response from the FDA. ReGenTree has completed preparation for all aspects of this approximately 500-patient, double-masked, placebo-controlled clinical study and is ready to immediately start the trial. Details of the trial will be submitted to www.clinicaltrials.gov.
“The FDA has strict criteria for approval of new drugs for the treatment of dry eye syndrome. Since the FDA has accepted ReGenTree’s clinical development plan and Phase 3 protocol based on the results of our previous phase 2b/3 trial, if our second Phase 3 trial is successful we believe ReGenTree may be able to submit an NDA based on the results of these two studies,” stated Won Yang, president and chief executive officer of GtreeBNT.
“ReGenTree plans to complete the Phase 3 trial by the 3rd quarter of 2017 in accordance with our development plan and is targeting NDA approval from the FDA in 2018, which would allow it to enter the U.S. market with a new drug to treat DES. Positive discussions with candidate partners for licensing are expected to continue as the direction of the clinical development plan is now resolved,” according to Mr. Yang.
“The acceptance of our Phase 3 plan by the FDA is a major milestone in the development of RGN-259 and we look forward to successfully completing this critical clinical trial next year,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer.
GtreeBNT is also developing drug candidates licensed from RegeneRx for two orphan indications. A protocol is being completed for a Phase 3 clinical trial for epidermolysis bullosa in preparation for a meeting with FDA, while a Phase 3 neurotrophic keratopathy clinical trial sponsored by ReGenTree is currently underway.
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 September 2015, RegeneRx, through its U.S joint venture, ReGenTree LLC, initiated a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome and a 46-patient Phase 3 clinical trial in patients with NK. The dry eye trial has been completed and results were announced in May 2016. 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 central nervous system tissue damage associated disorders such as multiple sclerosis and traumatic injuries such as stroke. For additional information about RegeneRx please visit www.regenerx.com.
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 the U.S. and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx, completed a Phase 2b/3 in patients with dry eye syndrome in 2016 and is sponsoring a Phase 3 clinical trial in patients with neurotrophic keratopathy (an orphan indication). RegeneRx currently holds a 42% interest in the joint venture, retains a royalty on commercial sales, and is represented on the board of ReGenTree. Certain commercial and financial transactions require RegeneRx approval. GtreeBNT is responsible for operations of the venture and all funding required for clinical development of RGN-259 in the U.S.
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 relate to the planned timing of clinical trials, potential results of such trials, and the actions that may be taken in response to such results. 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.