RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced the outcome of discussions between its US 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.
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tß4) and its constituent fragments, for tissue and organ protection, repair and regeneration.
ReGenTree is a US joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259 in the USA and Canada for ophthalmic indications.