AstraZeneca reveals OSKIRA-2 and OSKIRA-3 results

AstraZeneca has revealed top-line results for its OSKIRA-2 and OSKIRA-3 Phase III clinical trials, which investigate fostamatinib.

Fostamatinib is the first oral spleen tyrosine kinase inhibitor in development as an oral treatment for rheumatoid arthritis. In the OSKIRA-2 research, fostamatinib showed significant improvements in ACR20 response when combined with DMARDs at 24 weeks in both the 100mg twice daily group and candidates who received 100mg twice daily for four weeks followed by 150mg once daily compared to placebo.

Briggs Morrison, MD, executive vice-president of Global Medicines Development and chief medical officer, said: “The results of the late stage trials did not measure up to the promising results we saw earlier in development.

“We remain committed to the search for new treatments for patients with rheumatic and inflammatory diseases with Phase II compounds in rheumatoid arthritis and lupus and Phase III compounds in gout and psoriasis.”

Due to this, AstraZeneca will incur a pre-tax impairment charge of around $140 billion to research and development expenses in the second quarter of 2013 for assets relating to fostamatinib.

However, since intangibles are excluded from the business’ core financial measures, the impairment will have no impact on AstraZeneca’s financial guidance for 2013. The firm will continue to face research and development costs linked with the completion of ongoing studies for fostamatinib, meaning there are no changes to its guidance.

AstraZeneca confirmed an exclusive global license agreement with Rigel Pharmaceuticals in February 2010 for the global development and commercialisation of fostamatinib, with the company set to publish a more in-depth anlysis of the OSKIRA clinical programme.

In recent weeks, AstraZeneca welcomed its first patient to a Phase II clinical trial for moxetumob pasudotox, which is a treatment for non-responsive or relapsed hairy cell leukaemia patients.

The study will result in moxetumob passudotox being analysed as a potential treatment who have not reacted to standard therapy.

Posted by Fiona Griffiths