Solid results for AstraZeneca’s oral RA drug
pharmafile | September 23, 2010 | News story | Research and Development | AstraZeneca, Rigel, fostamatinib, rheumatoid arthritis
AstraZeneca’s new oral treatment for rheumatoid arthritis has produced solid results in a phase II trial.
Fostamatinib is the first oral syk inhibitor in development as a novel therapeutic approach for rheumatoid arthritis (RA). It is thought to reversibly block signalling in multiple cell types involved in inflammation and tissue degradation in RA.
If the drug proves to be a success, it could challenge the blockbusters of rheumatoid arthritis, including Enbrel, Remicade and Humira, which are only available as injections or infusions.
The drug was studied in patients whose disease was not responding adequately to ongoing treatment with methotrexate.
The six-month phase IIb study, known as TASKi2, showed 67% of patients taking fostamatinib 100mg twice daily achieved the primary efficacy endpoint (ACR 20).
ACR 20 is a standard measure of how many patients achieve a 20% improvement in five metrics – joint swelling, pain symptoms and physical function in the patient, and the overall assessment of the patient and of the doctor.
Fostamatinib’s results were significantly higher than placebo, paving the way for phase III trials to begin later this year.
AstraZeneca and its development partner Rigel underlined the fact that 36% of patients achieved an ACR 20 response after just one week, and said speed of onset may be an important factor in RA because permanent joint damage can occur when the disease is active.
“In this study, we saw a significant clinical benefit in this rheumatoid arthritis population and a manageable safety profile,” said Mark Genovese, Division of Rheumatology, Stanford University.
“Based on the data, further study of fostamatinib as an oral agent for the treatment of patients with rheumatoid arthritis is certainly warranted.”
The published data indicates that the most common drug-related adverse events in the study were diarrhoea (19% in 100mg bid group, 12% in the 150mg qd group and 3% in the placebo group), upper respiratory infection (15%, 7% and 7% respectively) and neutropenia (6%, 7% and 1% respectively).
Hypertension (BP>140/90) occurred more frequently in fostamatinib treated patients than placebo (29% across both fostamatinib groups compared to 17% in placebo group) as had been previously reported. The hypertension generally occurred within the first few weeks of therapy and was responsive to conventional anti-hypertensive medications.
AstraZeneca licensed fostamatinib from San Francisco-based clinical stage drug development company Rigel in February this year, making an upfront payment of $100 million and lining up further milestone-dependent payments of up to $345m.
AZ hopes to file fostamatinib for approval by US and European regulators in 2013.
Andrew McConaghie
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