US-based RegeneRx Pharmaceuticals's strategic partner G-treeBNT, a South Korean biotech firm, is preparing to submit an IND and 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.
The proposed Phase lll trial of RGN-259 (a Thymosin Beta 4-based preservative-free eye drop) is based on data generated in a 72-patient, double-masked, placebo-controlled trial sponsored by RegeneRx and conducted by Ora, an ophthalmic CRO in the US and Japan.
The 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.
The company said that both these trials resulted in statistically significant sign and symptom improvements in central cornea staining and ocular discomfort.
In the 72-patient trial conducted in the US, patients were diagnosed with moderate dry eye, treated with RGN-259 or placebo four times daily for 28 days, and assessed using Ora's controlled adverse environment (CAE) model.
In this trial, RGN-259 was found to be safe and well-tolerated, while patients had statistically significant improvements in several signs and symptoms of dry eye at several time points.
RegeneRx Biopharmaceuticals president and chief executive officer JJ Finkelstein said: "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 commercialise RGN-259 in 28 countries in Asia and Pacific Rim including South Korea, Japan and Australia."
In the nine-patient severe dry eye trial carried out at the Kresge Eye Institute in Detroit, RGN-259 was found to be safe and well-tolerated.
RGN-259 also met key efficacy objectives with statistically significant sign and symptom improvements, compared with vehicle control, at several time intervals, including 28 days post-treatment, which is consistent with the potentially protective effects observed in the Ora trial.
G-treeBNT president and chief executive officer Won Yang said: "If successful, this will facilitate the commercialisation of RGN-259 in other countries in Asia and the Pacific Rim that are covered by our strategic partnership with RegeneRx.
"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."