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news.UK biopharmaceutical firm Arakis Ltd has completed a phase IIa trial of AD 452, a treatment for rheumatoid arthritis, reporting encouraging tolerability data in combination with standard treatment.
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AD 452 is a novel, small molecule, disease modifying anti-rheumatic drug (DMARD), designed to reduce joint inflammation and destruction, pain, and preserve mobility.
The trial investigated the pharmacokinetics, safety and tolerability of AD 452 in 99 patients with rheumatoid arthritis (RA) in patients who were already receiving methotrexate. The results show that AD 452 was well tolerated at the three dose levels tested.
“We are very pleased with these results which show that AD 452 used in combination with the standard treatment of methotrexate for RA, is safe in patients,” commented Tim Sharpington, director of clinical operations at Arakis. “The study confirmed that AD 452 has an attractive pharmacokinetic profile following once-daily oral dosing.”
The next stage of AD 452’s development is to demonstrate its efficacy in combination with methotrexate in patients with active RA, in a three-month phase IIb dose ranging study due to start in September 2005. The study will be conducted in both the US and Europe and it is anticipated to take around a year to complete.