Arakis commences Phase IIB trial for rheumatoid arthritis drug
Sosei Co. Ltd. announcee that its wholly-owned subsidiary Arakis Ltd ("Arakis"), has commenced a Phase IIb dose ranging study of AD 452, a novel, small molecule, disease modifying anti-rheumatic drug (DMARD), designed to reduce joint inflammation and destruction, pain, and preserve mobility.
The study is a randomised, multi-centre, double blind, placebo controlled 12 week trial designed to evaluate the efficacy and safety of AD 452 on a background of methotrexate in patients with active rheumatoid arthritis (RA). A total of at least 292 patients in four treatment groups will be enrolled at study centres in Europe and the USA. The trial is being undertaken under US and EU regulatory authorisations and will take approximately one year to complete.
Results from the earlier Phase IIa trial completed in April 2005 confirmed that AD 452 has an attractive pharmacokinetic profile following once-daily oral dosing and was well tolerated at the three dose levels tested. RA is a type of chronic arthritis or inflammation of the lining of the joints with the potential to affect the entire body. Symptoms include joint pain, stiffness, warmth, redness and swelling. It may also include bone and cartilage breakdown, loss of joint shape, alignment and movement. Although the exact cause of RA is unknown, there appears to be a genetic component and an external trigger to the body's immune system causing it to attack healthy joint tissue.
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