RegeneRx Biopharmaceuticals, Inc, a biopharmaceutical company, engaged in discovery, development of molecules for tissue and organ repair, has announced that its South Korea based licensee GtreeBNT Co. Ltd. (Gtree), a world leading embedded UI provider, has received approval from the Ministry of Food and Drug Safety (MFDS) in Korea to conduct a phase 2b/3 clinical trial of GBT-201 in patients with dry eye syndrome (DES).

The phase 2b/3 clinical trial will be a multicenter, randomized, double-masked study that will be conducted in approximately 360 patients with DES. The trial will evaluate the efficacy and superiority of GBT-201 compared to placebo.

GBT-201/RGN-259 is a sterile, preservative-free eye drop designed to treat eye disorders such as DES and neurotrophic keratopathy (NK), among others. According to Gtree, it is the first pharmaceutical company in Korea to reach phase 3 clinical trial status for a new drug for the treatment of DES.

"Approval to initiate the Korean dry eye study represents a significant milestone for GBT-201/RGN-259. The Gtree team has been working very hard to prepare for this clinical trial, and we have been working closely with them to help expedite this effort. Patient enrollment is targeted for the end of September, and we look forward to receiving notice when the first patient is enrolled," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.

RGN-259 (designated GBT-201 in Korea) is a sterile, preservative-free topical eye drop for ophthalmic indications whose active ingredient is Thymosin beta 4 (TB4). Based on US phase 2 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 data from these trials, as well as a recently completed clinical trial of RGN-259 in patients with NK, reflect RGN-259's mechanisms of action, support the "protective" effects of RGN-259, and provide RegeneRx with FDA-approvable clinical endpoints to be targeted in future clinical trials. Dry eye syndrome is a multifactorial disease and it is well known that TB4 promotes cell migration and proliferation, modulates cytokines and/or chemokines related to inflammation, matures stem cells, and stimulates cell survival, all of which are believed to be important for effective treatment of DES.