RegeneRx Biopharmaceuticals, Inc.
) 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
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
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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