ReGenTree Announces Outcome of FDA Discussions for Development of RGN-259 for Dry Eye Syndrome
PRINCETON, N.J., April 9, 2018 (Newswire.com) - ReGenTree LLC (the "Company"), a joint venture between GtreeBNT and RegeneRx Biopharmaceuticals, announced today the outcome of discussions with 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. We are now planning to initiate the ARISE-3 trial this year," according to Mr. Won Yang, ReGenTree'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 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. 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.
Source: ReGenTree LLC