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Rigel's R348 To Initiate Phase 2 Clinical Trial In Dry Eye

SOUTH SAN FRANCISCO, Calif., May 22, 2013 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the clinical advancement of three programs in development. The first program is a wholly-owned topical ophthalmic formulation of a JAK/SYK inhibitor, R348, being developed by Rigel as a treatment for dry eye disease.  The other two programs are aimed at oncology targets and are being conducted by corporate partners, including an AXL kinase inhibitor under development by BerGenBio AS (BerGenBio) and a ligase inhibitor under development by Daiichi Sankyo Company, Limited (Daiichi Sankyo). 

"Our ophthalmic formulation of R348 was shown to be well tolerated in our recent Phase 1 study and we look forward to evaluating the drug candidate in patients with chronic dry eye disorders," said Raul Rodriguez, president and chief operating officer of Rigel. "In addition, for our two partnered oncology programs, we are pleased that our partners BerGenBio and Daiichi Sankyo have each taken steps to initiate first-in-human clinical studies with small molecules that represent novel approaches to treating a variety of solid and blood borne cancers," he added.

R348, Topical Ophthalmic JAK/SYK InhibitorChronic dry eye is an inflammatory disease that often affects the lacrimal (tear producing) glands of the eye.  Over five million Americans suffer with this disorder, and many patients with chronic dry eye may also suffer with autoimmune conditions, including systemic lupus erythematosus and rheumatoid arthritis.  Chronic dry eye is an irritating and painful disease that may be destructive to the cornea if not well controlled.

Rigel has developed a topical ophthalmic (eye drop) formulation of R348, a JAK/SYK inhibitor, aimed at reducing the underlying inflammation responsible for causing the symptoms of this condition.  A recently completed Phase 1 study of R348 in patients with dry eye disease showed that the drug candidate is well tolerated and Rigel expects to begin a Phase 2 study, titled DROPS (Dry eye Rigel Ophthalmic Phase 2 Study), shortly.  This multi-center, randomized, double-masked study, will evaluate two doses of R348 versus placebo administered twice a day over a three-month period in approximately 210 patients with dry eye disease.  The efficacy endpoints will include change from baseline in corneal staining, tear production and dry eye symptom scores.  Results of this Phase 2 study are expected in the first half of 2014.

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