ROCKVILLE, Md., Aug. 2, 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 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.
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