Rigel's R788 Demonstrates Significant Improvement in Rheumatoid Arthritis in Phase 2 Clin...(46 32% (15) 17% (8) 2% (1) ...),Health

100 mg 49 65% (32) 49% (24) 33% (16) 35% (17)

(p=.008) (p=.002) (p<.001) (p=.005)

150 mg 47 72% (34) 57% (27) 40% (19) 47% (22)

(p<.001) (p<.001) (p<.001) (p<.001)

Note: At 12 weeks. All patients were on stable doses of methotrexate

throughout the clinical trial and extension.

* The results presented are based on an intention to treat analysis that

includes all randomized patients, regardless of how long treatment

lasted. Any patient who dropped out of the study for any reason, or for

whom week 12 data was unavailable, was considered a treatment failure

(ACR non-responder). Disease Activity Scores are based on a 28 joint

count and CRP at week 12.

James M. Gower, chairman and chief executive officer of Rigel said, "These very important clinical trial results are a major milestone for Rigel as we establish the potential of R788 in RA and its value as an alternative to current therapies. In addition, given these results and the recent results in ITP, we believe that R788 may be a useful drug in the treatment of autoimmune diseases."

Safety Results

The most common clinically meaningful adverse events noted in the clinical trial were dose-related neutropenia, mild elevations of liver function tests, and gastrointestinal (GI) side effects. Dose reduction (to one half the assigned dose, by taking the drug once per day) was pre-specified in the protocol, contingent on neutrophil counts and/or liver function tests. Notably, a vast majority of the patients (19 out of 21) who had their dose reduced, successfully completed the clinical trial with minimal safety issues.

The key safety results are shown in the table below:

Placebo 50mg
'/>"/>