LITTLE CHESTERFORD, England, April 7 /PRNewswire/ -- Arakis Ltd, the biopharmaceutical company focusing on inflammatory disease and oncology adjunctive therapy, today announces that its treatment for rheumatoid arthritis ("RA"), AD 452, has successfully completed a Phase IIa trial. 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 RA. It was a double-blind, placebo-controlled, parallel group, 28-day study in patients who were already receiving methotrexate. The results show that AD 452 was well tolerated at the 3 dose levels tested. It was a multi-centre trial undertaken under US IND and EU CTA regulatory authorisations.
Tim Sharpington, Director of Clinical Operations at Arakis, said: "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. The study confirmed that AD 452 has an attractive pharmacokinetic profile following once-daily oral dosing. We can now progress AD 452's development to Phase IIb trials to show that it is also effective in treating RA."
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. The prevalence of RA is estimated at 1% of the population worldwide which equates to approximately six million people; 75% of whom are women. Significantly, after ten years of RA, fewer than 50% of patients can continue to work or function normally on a day to day basis.
Ken Cunningham, Arakis' Chief Executive Officer, said: "Despite the introduction of new drugs, rheumatologists still need more ways to treat RA due to its variable and long-term nature and the side effects often suffered from the current medication. We believe that AD 452 used in combination with methotrexate will provide an effective and safe weapon in combating this debilitating disease."
The next stage of AD 452's development is to demonstrate its efficacy in combination with methotrexate in patients with active RA, in a 3 month Phase IIb dose ranging study due to start in September 2005. Efficacy will be assessed by the measurement of ACR20 and DAS28 scores. The study will be conducted in both the USA and Europe and it is anticipated that it will take around a year to complete.
Notes to Editors:
Pharmacokinetics: the way in which the body deals with a drug. This includes the drug's absorption, distribution in the tissues, metabolism and excretion.
ACR scores: the widely accepted composite scale of improvement in RA, developed by the American College of Rheumatology (ACR). The number refers to the percentage improvement in swollen joint count, tender joint count and three or more of the following measures: patient's own assessment of disease activity; physician assessment of disease activity; patient's own assessment of RA pain; acute-phase reactant (ESR, CRP) and disability questionnaire.
DAS28 or Disease Activity Score28: is a composite measure which is used to assess disease activity in patients with RA. DAS28 (CRP) incorporates the measurement of the number of tender and swollen joints, C-reactive protein and patient global assessment.
Current treatment regime for patients with RA
Early treatment of RA is with small molecule Disease Modifying Anti-Rheumatic Drugs or DMARDs such as methotrexate - currently the most commonly prescribed DMARD - which slows down the progression of the disease. However, treatment is often discontinued for reasons of limited efficacy or side effects. For more severe or advanced conditions, the newer biological DMARDs may to be used, but only as a second or third line treatment due to their high cost, currently in excess of $10,000 per patient per year and potential side effects. Side effects from DMARDs include increased susceptibility to infection, hair loss, the suppression of blood cell formation in bone marrow, kidney or liver damage. Not surprisingly, physicians are increasingly looking at combining different RA drugs for a more effective treatment regime.
Arakis is a private UK based biopharmaceutical company that discovers, develops and commercialises innovative medicinal products based on established drugs and drug templates. Its main therapeutic areas are inflammatory disease and oncology adjunctive therapy.
Arakis has four products in clinical development: AD 237 for chronic obstructive pulmonary disease (COPD) and AD 452 for rheumatoid arthritis (RA) which have completed Phase IIa trials and AD 337 for fibromyalgia syndrome and AD 923 for cancer breakthrough pain (CBP) which are in Phase I. In addition, there is a preclinical pipeline of 3 opportunities to treat pain indications. For further information please see http://www.arakis.com/