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news.G-treeBNT, a South Korean biotech firm and strategic partner of US-based RegeneRx Pharmaceuticals, is preparing to file an IND as well as sponsor a Phase III clinical trial with RGN-259 in patients with moderate to severe dry eye initially in South Korea, followed by Japan and Australia, with follow-on registrations in certain additional Asian and Pacific Rim countries if appropriate.
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The trial of RGN-259 (a Thymosin Beta 4-based preservative-free eye drop) is based on data secured from a 72-patient, double-masked, placebo-controlled trial sponsored by RegeneRx and conducted by Ora, an ophthalmic CRO in the US and Japan.
The Phase lll trial is also based on data from a recently completed nine-patient physician-sponsored, double-masked, placebo-controlled clinical trial in patients with severe dry-eye syndrome, both conducted in the US.
According to the company, both these trials resulted in statistically significant sign and symptom improvements in central cornea staining and ocular discomfort.
RegeneRx Biopharmaceuticals president and chief executive officer JJ Finkelstein said with two RGN-259 Phase II dry eye trials completed in the US, the company is happy that its strategic partner, G-treeBNT, intends to move into Phase III.
"We have been working closely with G-treeBNT on the development of RGN-259 and a successful Phase III clinical trial in Asia would be a critical milestone as G-treeBNT has the rights to commercialize RGN-259 in 28 countries in Asia and Pacific Rim including South Korea, Japan and Australia," Finkelstein said.
G-treeBNT president and chief executive officer Won Yang said the company has decided to initially file an IND for a Phase III clinical trial with RGN-259 in South Korea, followed by a similar strategy in Japan and Australia.
"If successful, this will facilitate the commercialization of RGN-259 in other countries in Asia and the Pacific Rim that are covered by our strategic partnership with RegeneRx," Yang said.
"Our target is to submit an IND for Phase III within 2014 in order to achieve the first patient recruitment before the end of the first quarter of 2015."