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Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial
Date:7/9/2009

SOUTH SAN FRANCISCO, Calif., July 9 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. The groups treated with 100 mg of R788 bid (twice a day) and 150 mg qd (once a day) reported higher ACR 20, ACR 50, ACR 70 and DAS28 response rates than the placebo group. The efficacy results for the two dosing groups were comparable, although the response rates for the 100 mg bid group was uniformly greater. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.

Rigel will host a conference call today at 8:00am EDT/5:00am PDT to discuss these results (see conference call details below).

"These are impressive results," said James M. Gower, chairman and chief executive officer of Rigel. "The data from this clinical trial and the soon to be completed TASKi3 clinical trial, a total of over 670 patients, will guide the design of the Phase 3 trials that we plan to launch with a corporate partner in the first half of next year, " he added.


    Efficacy Results

    Treatment    N of Pts   ACR 20     ACR 50    ACR 70    DAS28<2.6

    Placebo        153      53 (35%)   29 (19%)  16 (10%)  9 (
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SOURCE Rigel Pharmaceuticals, Inc.
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