RegeneRx Pharmaceuticals and G-treeBNT Co. Ltd. have jointly announced that G-treeBNT is preparing to file an IND and sponsor a Phase III clinical trial with RGN-259 (a Thymosin Beta 4based preservative-free eye drop) 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.

The proposed Phase lll trial is based on data generated in a 72-patient, double-masked, placebo-controlled trial sponsored by RegeneRx and conducted by Ora, Inc., an ophthalmic CRO in the U.S. and Japan, as well as data generated in a recently completed 9-patient physician- sponsored, double-masked, placebo-controlled clinical trial in patients with severe dry-eye syndrome, both conducted in the U.S. Both Phase II trials resulted in statistically significant sign and symptom improvements in central cornea staining and ocular discomfort.

In the 72-patient trial in the U.S., patients were diagnosed with moderate dry eye, treated with RGN-259 or placebo four times daily for 28 days, and evaluated using Ora's proprietary controlled adverse environment (CAE) model. RGN-259 was found to be safe and well-tolerated and patients had statistically significant improvements in several signs and symptoms of dry eye at several time points during the study, offering protective effects when patients were challenged in the CAE model.

In a 9-patient severe dry eye study conducted at the Kresge Eye Institute in Detroit, RGN-259 was found to be safe and well-tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at various time intervals, including 28 days post-treatment, which is consistent with the potentially protective effects observed in the Ora study.

The reduction of fluorescein staining is indicative of a reduction in ocular surface damage of the cornea while improvement in ocular discomfort reflects how the patient's eye feels. The effects of RGN-259 were seen relatively quickly and there were no adverse events associated with the drug in Phase II. These results reflect the known mechanisms of action of RGN-259.

About RegeneRx Pharmaceuticals, Inc.

RegeneRx is in development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and...

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