AD 452: successful completion of Phase IIa trial

[Guest guest]

AD 452: successful completion of Phase IIa trial

http://www.mysan.de/article72746.html

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: Glossary

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.

About Arakis

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.