Clinical-stage drug development firm RegeneRx Biopharmaceuticals licensee GtreeBNT has obtained approval from the Ministry of Food and Drug Safety (MFDS) in Korea to carry out a Phase IIb / III clinical trial of GBT-201 (RGN-259) in patients with dry eye syndrome (DES).
GBT-201 is a sterile and preservative-free eye drop developed to treat eye disorders, such as DES and neurotrophic keratopathy (NK) among others.
The study will be a multi-centre, randomised, and double-masked trial, which will include approximately 360 patients with DES.
The trial will assess the efficacy and superiority of GBT-201 compared to a placebo.
RegeneRx Biopharmaceuticals president and CEO 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."
RGN-259 includes active ingredient is Thymosin beta 4 (TB4). It found to demonstrate statistically significant improvements in several signs and symptoms of dry eye, as well as positive trends in other outcome measures, based on US Phase II clinical trials in moderate and severe dry eye syndrome.
Based in Gyeonggi-do of South Korea, G-treeBNT is developing GBT-201, its first drug candidate for dry eye syndrome in 28 Asian and Pacific Rim countries.