Anglo-Swedish drug maker AstraZeneca Plc (AZN, AZN.L) announced top-line results of OSKIRA-1, a Phase 3 study to assess the efficacy and safety of fostamatinib, oral spleen tyrosine kinase or SYK inhibitor in development for rheumatoid arthritis or RA.
OSKIRA-1 had two primary endpoints: assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS or modified Total Sharp Score.
The company noted that in the OSKIRA-1 study, fostamatinib achieved a statistically significant improvement in ACR20 response rate at 24 weeks in both the 100 mg twice daily group and the group that received 100 mg twice daily for four weeks followed by 150 mg once daily (49%, p<0.001 and="" 44%,="" p="0.006" respectively)="" compared="" to="" placebo="">
The company said that Fostamatinib did not demonstrate a statistically significant difference in mTSS compared to placebo at 24 weeks for either dose (p=0.252 and p=0.170, respectively).
According to the company, the safety and tolerability findings for fostamatinib observed in the OSKIRA-1 study were generally consistent with those previously reported for the TASKi Phase 2 program. The most commonly reported adverse events were typical of those seen in earlier studies, including hypertension, diarrhea, nausea, headache and nasopharyngitis (common cold).
Briggs Morrison, executive vice president of Global Medicines Development and chief medical officer, said, "These top-line results provide important information on the efficacy and safety of fostamatinib and demonstrate that the compound has an effect on the signs and symptoms of rheumatoid arthritis."
The company said it will await the results of the remaining Phase 3 studies, OSKIRA-2 and OSKIRA-3, to further evaluate and characterize the profile of fostamatinib as a potential treatment for rheumatoid arthritis. The OSKIRA-2 and OSKIRA-3 results are expected later in the second quarter of 2013.
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