RegeneRx Biopharmaceuticals, a company focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration, announced that its strategic partner, G-treeBNT Co. Ltd., has filed an IND with the Korean Ministry of Food and Drug Safety (MFDS) for a phase IIB/III clinical trial with RGN-259 (designated GBT-201 in Korea and the licenced Pan Asia territory) for the treatment of patients with dry eye syndrome.
"We are pleased G-treeBNT has filed an IND this year with MFDS as they stated they would last March when we entered into the partnership. Moreover, they have assembled an extremely experienced team of pharmaceutical professionals who have accomplished quite a bit in a short period of time in order to file the IND. We look forward to initiation of the trial in Korea in 2015, followed by other countries in Asia," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.
"Our goal with GBT-201, a preservative-free eye drop (with Thymosin beta 4 as the active ingredient) for the treatment of dry eye syndrome, is to become a market leader within 3-4 years. The global market for dry eye prescription medications was approximately $1.1 billion as of 2013, and we are devoting substantial resources to enter this market space by creating significant value with GBT-201, which is unique among approved products and product candidates for this indication. The market demand for a new drug with an innovative mechanism of action is very high," stated Won S. Yang, president and chief executive officer of G-treeBNT.
G-treeBNT received exclusive development and commercialization rights in March 2014 from RegeneRx for RGN-259 (GBT-201) for dry eye syndrome in 28 Asian and Pacific Rim countries including Korea, Japan and Australia. RegeneRx will receive royalties and milestone payments upon commercialisation in the territory.
RGN-259 (GBT-201) is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (TB4). Based on two US phase II clinical trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures. The results from these trials reflect RGN-259's mechanisms of action, appear to support the "protective" effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials.