US-based tissue regeneration-focused RegeneRx has announced it is accelerating the development of RGN-259 in China for a range of ophthalmic indications in collaboration with its partner Hong-Kong-based Lee’s Pharm.
Lee’s Pharm previously licensed the preservative-free, sterile topical eye drop for ophthalmic indications, including dry eye syndrome and neurotropic keratitis (NK), in Greater China, which encompasses China, Macau, Hong Kong and Taiwan.
This announcement follows a previous acceleration announcement in 2016 following the news that the China Food and Drug Administration (CFDA) no longer required Phase I and II clinical trials to be conducted from products made entirely in China. This sped up development since it meant RegeneRx could provide thymosin beta 4, the active ingredient in RGN-259, to Lee’s Pharm.
However, China-based Phase III trials need to be conducted with a drug candidate fully manufactured in China. These trials will be supported through Lee’s Pharma’s new manufacturing facility; in addition to investing $200,000 in RegeneRx as part of convertible debt financing, Lee’s Pharm has built a 60,000 square foot (sqft) production area and 22,000sqft warehouse area to develop, manufacture and market ophthalmic drugs.
RegeneRx president and CEO J.J. Finkelstein said: “We are pleased Lee’s Pharm is accelerating its effort to develop RGN-259 and recognize that it could have a significant impact on the treatment of numerous ophthalmic disorders in China.
“With its new manufacturing facility, Lee’s Pharm is now in a position to effectively develop and commercialize RGN-259. We look forward to helping in every way we can with this effort,”
Lee’s Pharm CEO Dr Benjamin Li said: “With our recently created subsidiary, China Ophthalmology Focus Limited, and our new ophthalmic manufacturing facilities, we are now well-positioned to accelerate development of RGN-259 in China for dry eye syndrome and other ophthalmic disorders.
“RGN-259 is an exciting product candidate, with significant clinical data supporting its safety and efficacy and fits well into our current product development strategy in the ophthalmic field.”
RGN-259 is one of RegeneRx’s core products. The US Food and Drug Administration (FDA) has granted the drug orphan drug designation for the treatment of NK, a rare corneal defect.
RegeneRx subsidiary ReGenTree has recently initiated a Phase III study of the drug in dry eye syndrome.