RegeneRx and Lee's Pharmaceutical Dry Eye Drug Progresses - Analyst Blog

RegeneRx Biopharmaceuticals, Inc. (RGRX) and its Hong Kong-based partner Lee's Pharmaceutical Holdings Ltd. announced that the Chinese regulatory authority has accepted a phase II investigational new drug IND application for their ophthalmic candidate, RGN-259. RegeneRx and Lee's Pharma expect to initiate a phase II study in the first quarter of 2015.

RGN-259 is a thymosin beta 4-based, preservative-free eye drop. The companies plan to evaluate the candidate in patients suffering from moderate-to-severe dry eye syndrome in China.

We remind investors that RegeneRx had entered into a licensing agreement with Lee's Pharma in Jul 2012 for several pipeline candidates including RGN-259 in China, Hong Kong, Macau and Taiwan.

Previous Studies on RGN-259

In Jun 2012, RegeneRx reported preliminary results from a double-masked, vehicle-controlled, physician-sponsored phase II study on RGN-259 for the treatment of severe dry eye. The study met its key efficacy objectives with statistically significant sign and symptom improvements observed in the RGN-259 arm as compared to the vehicle control arm, at various time intervals, including 28 days post-treatment. Additionally, RGN-259 was also found to be safe and well-tolerated.

Prior to this, the company had reported preliminary safety and efficacy data from phase IIa exploratory study on RGN-259 for moderate dry eye syndrome. However, the study failed to meet a co-primary endpoint.

RegeneRx is planning on developing RGN-259 for several ophthalmic indications, including pursuing clinical development for the treatment of dry-eye syndrome and neurotrophic keratopathy (NK). RGN-259 enjoys orphan drug designation for the NK indication.

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