12 April 2018 - - Rockville, Maryland-based clinical-stage drug development company RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) US joint venture, ReGenTree LLC, has completed discussions with 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, the company said.
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 US to work with key opinion leaders as well as meet with potential strategic partners.
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. RGN-259 has been designated an orphan drug in the US for the treatment of NK.
ReGenTree is a US joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259 in the US and Canada for ophthalmic indications.
RegeneRx develops novel therapeutic peptides, including Thymosin beta 4 and its constituent fragments, for tissue and organ protection, repair and regeneration.
It currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the US, 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.