Lee's Pharmaceutical Ltd., RegeneRx's licensee in China, Hong Kong, Macau and Taiwan, received notice from China's FDA (CFDA) declining its investigational new drug (IND) application for a Phase 2b dry eye clinical trial because the API (active pharmaceutical ingredient or TB4) was manufactured outside of China. The API was manufactured in the U.S. and provided to Lee's by RegeneRx pursuant to a license agreement to develop RGN-259 ophthalmic eye drops in the licensed territory.
G-treeBNT, RegeneRx's licensee in Korea, Australia, Japan and a number of other countries in Asia, recently received permission from the Korean Ministry of Food and Drug Safety (MFDS) to begin its Phase 2b/3 clinical trial for dry eye syndrome in Korea. Given its immediate focus on the two U.S. trials, G-treeBNT is considering the best timing for the Korean trial.
"Both U.S. ophthalmic trials are moving forward as expected, and we are pleased Lee's is quickly moving their Phase 2b trial to Hong Kong and Taiwan using the U.S.-produced TB4 while they separately manufacture it in China to satisfy the CFDA. We agree with their clinical strategy and support them. Similarly, we support G-tree's timing considerations in Korea while they utilize their resources to ensure the U.S. clinical trials continue to progress according to plan," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.
RegeneRx recently announced that its U.S. Phase 2b/3 dry eye clinical trial, conducted by Ora Inc., has enrolled over 125 of 350 patients in the first month and its U.S. Phase 3 neurotrophic keratopathy trial, a smaller study in an orphan population, has enrolled several patients to date. Both trials are expected to be completed in early 2016 and report data shortly thereafter.