RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its licensee for RGN-137, GtreeBNT, has entered into a joint venture with YuYang DNU, a Korean company, to develop RGN-137 on a global basis for the orphan indication, epidermolysis bullosa (EB). The joint venture between the two companies is Lenus Therapeutics, LLC (Lenus), a GtreeBNT U.S. subsidiary. Gtree will contribute the intellectual property rights and all development results for RGN-137 and YuYang will invest about $17.8 million in cash into Lenus.
According to GtreeBNT's press release, prior to a Phase 3 study planned for next year, Lenus is first planning to conduct an open study to attract big pharma, which has expressed ongoing interest in the product. The Phase 3 trial is then expected to enroll approximately 200 subjects around the world, including in the U.S.
EB is a rare genetic disease that most often appears in the skin, although it can also affect internal organs. There are currently no medications approved for the treatment of EB. RGN-137, a topical gel initially developed by RegeneRx Biopharmaceuticals, Inc., is the one of the only late stage treatment candidates and currently the subject of clinical trials in the United States. According to GtreeBNT, the industry estimates the potential market for EB to be between $1.5-2.0 billion world-wide. If RGN-137 receives marketing approval, it will obtain market exclusivity as an orphan drug in the U.S. and Europe.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (T?4) 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 T?4-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 T?4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition. The Company's licensee, GtreeBNT, is sponsoring a clinical trials in the U.S. and Europe and is expected to initiate an open study in 2018.
For additional information about RegeneRx please visit www.regenerx.com.
