Advertisement RegeneRx's GtreeBNT gets Korean approval for Phase IIb/III trial of RGN-259 in patients with DES - Pharmaceutical Business review
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RegeneRx’s GtreeBNT gets Korean approval for Phase IIb/III trial of RGN-259 in patients with DES

US-based RegeneRx Biopharmaceuticals' licensee GtreeBNT has received approval from the Ministry of Food and Drug Safety (MFDS) in Korea to carry out a Phase IIb/III clinical trial of RGN-259 (GBT-201) in patients with dry eye syndrome (DES).

About 360 patients with DES will be included in the multicenter, randomized, double-masked Phase IIb/III trial, which 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).

According to Gtree, it is the first pharmaceutical company in Korea to reach Phase III clinical trial status for a new drug for the treatment of DES.

RegeneRx president and chief executive officer JJ Finkelstein said: "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."

RGN-259 is developed for ophthalmic indications whose active ingredient is Thymosin beta 4 (TB4).

Based on US Phase II trials in moderate and severe dry eye syndrome, RGN-259 showed statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures.