Arakis, the UK biopharmaceutical company focusing on inflammatory disease and oncology adjunctive therapy, says that its treatment for rheumatoid arthritis, AD 452, has successfully completed a Phase IIa trial, and its development will be further progressed later this year.
The 28-day trial included 99 patients with RA who were already receiving methotrecate and aimed to assess the pharmacokinetics, safety and tolerability of this disease modifying anti-rheumatic drug, which is designed to reduce joint inflammation and destruction, pain, and preserve mobility. The results show that AD 452 was well tolerated at the three dose levels tested. 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, which is due to start in September 2005 and will take around one year to complete.
Although the market for RA treatments could prove competitive for Arakis, with market analysis firm, Datamonitor, last year stating that physicians are becoming increasingly concerned about side effects and drug costs rather than efficacy [[06/08/04h]], the firm believes its drug could offer new hope for RA patients. Said chief executive, Ken Cunningham: “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.”