Rigel Pharma’s R788 Passed Phase II Clinical Trial in Rheumatoid Arthritis

An oral syk kinase inhibitor, R788 (tamatinib fosdium) – product of Rigel Pharmaceuticals – has demonstrated statistically significant results in treating Rheumatoid Arthritis (RA) patients in a recently completed Phase 2 clinical trial.

Groups treated with R788 at 100mg and 150mg po bid (orally, twice daily), showed higher ACR20, ACR50, ACR70 and DAS28 response rates than the placebo group.

The efficacy results for the 100mg and the 150mg dose groups were fairly comparable. Dramatically, the onset of the effect in these dose groups occurred as early as one week after initiation of therapy.

We believe that the significant ACR scores and good tolerability observed in this clinical trial, and the further benefit of oral delivery may make R788 a favorable alternative to the currently marketed biological agents.

We all know how bad rheumatoid arthritis is. It is both an inflammatory and an autoimmune disease, affecting more that 2 million people in the U.S. alone, both young and old.

R788 is a novel, orally available syk kinase inhibitor designed to interrupt the cellular signaling at the trigger point of inflammation, thereby stopping the progression of the disease.

According to Elliott Grossbard, M.D., senior vice president of medical development at Rigel:

“This clinical study has shown that R788 treatment can achieve impressive ACR response rates.

In this clinical trial both the 100mg and 150mg doses improved arthritis symptoms and did so quickly.

We plan to initiate the next clinical trial with R788 in RA in 2008.”

Above were the results of a Phase 2 clinical trial. Next step will be Phase 3. After which, the FDA will review the data for approval before the said drug will hit available to be available to doctors and patients.

According to James M. Gower, chairman and chief executive officer of Rigel:

“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.”

Find more details from CNN Money and the Rigel Pharma PR.