Anglo-Swedish drug maker AstraZeneca Plc (AZN,AZN.L) on Friday said that a phase III study to assess the efficacy and safety of its drug candidate Fostamatinib for rheumatoid arthritis met one primary endpoint, while it failed in its second primary goal.
The trial, dubbed OSKIRA-1, had two primary endpoints namely, assessing signs and symptoms of rheumatoid arthritis as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified Total Sharp Score).
While Fostamatinib achieved a statistically significant improvement in ACR20 response rate compared to placebo in the trial, it failed to achieve statistical significance in mTSS.
The company added that the safety and tolerability findings for Fostamatinib observed in the OSKIRA-1 study were generally consistent with those previously reported for the TASKi Phase II program.
In the study, the most commonly reported adverse events were typical of those seen in earlier studies, including hypertension, diarrhoea, nausea, headache and nasopharyngitis or common cold.
RA is a systemic autoimmune disease in which the immune system attacks the joints, causing pain, swelling to the surrounding tissue and damage to the cartilage and bone. If not adequately treated, RA can destroy cartilage and bone within joints, leading to serious disability.
Clinical-stage drug development company Rigel Pharmaceuticals, Inc. (RIGL) developed the compound, and in February 2010, AstraZeneca signed a worldwide license agreement to develop and commercialise fostamatinib, previously referred to as R788.
The ongoing OSKIRA program has been designed to investigate fostamatinib as a potential new oral treatment option for RA and an alternative to injectable therapies for patients with an inadequate response to conventional Disease Modifying Anti-Rheumatic Drugs, including methotrexate and those with an inadequate response to TNF-a antagonists.
Briggs Morrison, Executive Vice President of Global Medicines Development and Chief Medical Officer, said, "We will await the results of the remaining Phase III studies, OSKIRA-2 and OSKIRA-3, to further evaluate and characterise 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.
In London, AstraZeneca shares are currently trading at 3,290 pence, up 1.50 pence or 0.05 percent.
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