Analyst Research

Report Title Price
Provider: MacroRisk Analytics/EconomicInvestor
$25.00
Provider: ValuEngine, Inc.
$25.00
Provider: S&P Capital IQ – STARS Reports
$127.00
Provider: Pechala's Reports
$25.00

NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.

AstraZeneca PLC Announces Results from Phase III OSKIRA Trials of Fostamatinib and Decides to Return Rights to Compounds to Rigel Pharmaceuticals


Tuesday, 4 Jun 2013 02:07am EDT 

AstraZeneca PLC announced that results from OSKIRA-2 and OSKIRA-3, the remaining pivotal Phase III clinical trials investigating fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development as an oral treatment for rheumatoid arthritis (RA). In the OSKIRA-2 study of patients inadequately responding to disease modifying anti-rheumatic drugs (DMARDs), fostamatinib in combination with DMARDs showed statistically significant improvements in ACR20 response rates at 24 weeks in both the 100mg twice daily group and the group receiving 100mg twice daily for four weeks followed by 150mg once daily. In the OSKIRA-3 study of patients inadequately responding to methotrexate (MTX) and a single TNF-alpha antagonist, fostamatinib in combination with MTX showed statistically significant improvements in ACR20 response rates at 24 weeks in the 100mg twice daily group (36.2%, p=0.004) but not in the group given 100mg twice daily for four weeks followed by 150mg once daily (27.8%, p=0.168) compared to placebo (21.1%). The safety and tolerability findings for fostamatinib observed in the OSKIRA Phase III program were generally consistent with those previously reported in earlier studies. Based on the totality of results AstraZeneca has decided not to proceed with regulatory filings for fostamatinib. AstraZeneca will return the rights to the compound to Rigel Pharmaceuticals which will decide whether it will continue the ongoing studies and pursue regulatory filings.