EULAR: Novel Arthritis Drug ML3000 May Offer Better Outcome For Arthritis Patients
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EULAR: Novel Arthritis Drug ML3000 May Offer Better Outcome For Arthritis Patients

By Olwen Glynn Owen

PRAGUE, CZECH REPUBLIC -- June 17, 2001 -- A new compound, ML3000, might offer significant advantages over current treatments in controlling pain and inflammation without compromising the gastrointestinal mucosa, researchers claim.

Speaking at the European League Against Rheumatism (EULAR) meeting, Professor Kim Rainsford of Sheffield Hallam University, in Sheffield, England, said ML3000, which is in final stage clinical development, is the first compound designed to treat patients with osteoarthritis by inhibiting both leukotrienes and prostaglandins via the 5-LOX (lipoxygenase) and COX (cyclo-oxygenase) pathways.

The agent, he said, might have a reduced potential for the gastrointestinal problems seen with nonsteroidal anti-inflammatory drugs (NSAIDS), Prof. Rainsford said.

Clinical Phase IIb studies involving 404 patients show this combination at doses of 100 mg, 200 mg and 400 mg twice a day is superior to placebo and as effective as diclofenac 50 mg three times daily in achieving pain suppression in osteoarthritis of the knee.

Furthermore the drug caused fewer gastrointestinal complications than did diclofenac. Similar protective effects were revealed in a comparative study with the NSAID naproxen.

Additionally, ML3000 inhibits platelet aggregation, so that the low dose aspirin given to patients treated with some COX-2-selective drugs, and which compromises their gastroprotective properties, may not be required.

The drug has also been studied in 109 patients with rheumatoid arthritis. In a double-blind, randomized, placebo-controlled trial, it produced a "clinically relevant reduction in tenderness and swelling of joints compared to placebo," according to the German pharmaceutical manufacturer, Merckle which discovered and is developing it.

Professor Stefan Laufer, Head of Pharmaceutical Chemistry at Tuebingen University, Germany commented: "We should think LOX not just COX if we really want to maximise the efficacy, tolerability and safety of treatments for arthritis patients and potentially broaden the option to include those conditions where current new treatments are contraindicated -- such as cardiovascular, renal and patients with respiratory impairment."

ML3000 is currently in Phase III trials.

SOURCE: PeerView Press

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