RegeneRx Announces Outcome of FDA Discussions for Development of RGN-259 for Dry Eye Syndrome
Published: Apr 09, 2018
ROCKVILLE, Md., April 9, 2018 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced the outcome of discussions between its U.S. joint venture, ReGenTree LLC, and the FDA regarding the results of the completed phase 3 clinical trial (ARISE-2) and the future development requirements for a New Drug Application ("NDA") submission of RGN-259, a novel drug candidate to treat dry eye syndrome.
"Although the FDA is requiring an additional phase 3 trial (ARISE-3) to further demonstrate efficacy in both signs and symptoms of dry eye in a larger patient population, all safety data from ARISE-1 and ARISE-2 were accepted by the FDA, no additional nonclinical efficacy and safety studies are required by the FDA, and the Company's chemistry and manufacturing control plans for the drug substance and drug product were considered complete and acceptable for NDA submission. ReGenTree is now planning to initiate the ARISE-3 trial this year," according to Mr. Won Yang, ReGenTree's president and chief executive officer.
"We are pleased that we are moving forward with development of RGN-259 for dry eye and that our partner has effectively completed the comprehensive and expensive ancillary work required for an NDA, including the numerous toxicology, stability and manufacturing studies required to bring a new drug to the market," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.
The ReGenTree team will attend the upcoming ARVO (The Association for Research in Vision and Ophthalmology) 2018 annual meeting to be held on April 29-May 3 in the U.S. to work with key opinion leaders as well as meet with potential strategic partners.
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.
RegeneRx, through its U.S joint venture, ReGenTree LLC, recently completed patient enrollment and treatment in its second Phase 3 clinical trial in approximately 600 patients with dry eye syndrome, reported positive clinical results with no safety issues. ReGenTree is also conducting a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK) targeted for completion in 2018. Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.
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 disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke.
RGN-137, also designated an orphan drug in the U.S., is the Company's Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition. The Company's licensee, GtreeBNT, is sponsoring a phase 3 clinical trial in the U.S. and is expected to initiate the study in 2018.
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.A. 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 2/3) and ARISE-2 (Phase 3). In addition to dry eye, the company is currently conducting a Phase 3 study for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit www.regentreellc.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. There can also be no assurance that the Company will apply for an NDA in the future or that if the Company applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. 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, 2017, 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.
CONTACT: For RegeneRx: Lori Smith, 301.208.9191, firstname.lastname@example.org
SOURCE RegeneRx Biopharmaceuticals, Inc.
Company Codes: OTC-QB:RGRX, OTC-PINK:RGRX, OtherOTC:RGRX