SOUTH SAN FRANCISCO, Calif., Sept. 6, 2012 -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has commenced Phase 2 clinical studies with two of the company's most advanced proprietary therapeutic product candidates. R343 is an inhaled SYK inhibitor that is being evaluated as a potential treatment for allergic asthma. R333 is a topical JAK/SYK inhibitor aimed at treating various phases of discoid lupus erythematosus (DLE, or lupus of the skin).
"R343 and R333 are leading the way in a substantial lineup of proprietary product candidates in Rigel's pipeline," said James M. Gower, chairman and chief executive officer of Rigel. "In addition to fostamatinib, which is in Phase 3 with our partner AstraZeneca, we now have two products in Phase 2 clinical studies and several more in, or preparing to enter, the clinic. Rigel continues to demonstrate its R&D productivity," he added.
Phase 2 Study of R343, an inhaled SYK inhibitor
Approximately 270 adults with allergic asthma will be randomized into the three arms of this Phase 2 clinical study of R343, called SITAR (SYK Inhibition for Treatment of Asthma with R343), for eight weeks of treatment with either of two different doses of the study agent or placebo. The primary endpoint of this double-blind, multi-center study will be the measurement of each patient's change in FEV1 (the maximum amount of air a person can forcefully exhale in one second) from baseline to dosing completion. Rigel will be using the 3M™ Taper Dry Powder Inhaler device for this trial. Rigel expects to complete this study in 2013.
Phase 2 Study of R333, a topical JAK/SYK inhibitor
In this Phase 2, double-blind, multi-center study, called SKINDLE (SYK Kinase Inhibition for DLE), more than 50 patients with active discoid skin lesions from DLE or Systemic Lupus Erythematosus (SLE) will be randomized into two groups. One group will receive R333 in a topical ointment and the other a placebo ointment to be administered on the lesions twice daily for four weeks. The primary endpoints of this study will be the measurement of each person's decrease in the total combined Erythema and Scaling Score of all treated lesions from baseline to Day 28. Rigel expects to complete this study in 2013.
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