Rigel Reports Positive Results For Phase 2b RA Trial
Plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program
Rigel has announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients. The results were obtained from the recently completed TASKi2 phase 2b clinical trial of 457 patients treated for up to six months.
The groups treated with 100mg of R788 bid (twice a day) and 150mg 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 100mg bid group was uniformly greater. Consistent with the previous phase 2a clinical trial, the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained, said the company.
The 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 in the first half of 2010.
James Gower, Chairman and CEO of Rigel, said: These are impressive results. 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.
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