Active Biotech will also give a poster presentation under the title "Laquinimod inhibits the development of murine experimental autoimmune encephalomyelitis in IFN-b-/- and in wild type mice". The study shows that laquinimod inhibits disease development of chronic EAE and histopathological changes in the CNS and is not dependent on beta-interferon for its therapeutic effect. This means that SAIK-MS can slow down the progress of the disease even in the absence of beta-interferon which indicates that SAIK-MS may have a broader field of application than this treatment opportunity currently on the market.
The clinical Phase II study included 209 patients (67 on placebo, 68 and 74 on 0.1 and 0.3 mg laquinimod respectively).
In addition to safety and tolerability, the primary objective with the study was to study the efficacy on development of active brain MRI lesions after daily oral treatment with laquinimod over 24 weeks. Treatment with 0.3-mg laquinimod showed a statistically significant reduction of the MRI activity (mean cumulative number of active lesions) by 44% compared to placebo. The reduction was even more pronounced (52%) in a subgroup of patients with active MRI lesions prior to the start of the study treatment. The overall number of patients with clinical relapses was low (approximately 25%) and disability scores were stable in all groups. No statistical significant differences between groups, with respect to these parameters, were detected. The safety profile for laquinimod was favourable.
The conclusion from the study is that the oral laquinimod in a dosage of 0.3 mg daily is well tolerated and effective in suppressing development of active brain MRI lesions in relapsing MS.
"There is a large medical need for a safe and effective oral treatment of MS and these promising results give hope that laquinimod tablets could meet this need",
says Professor Chris Polman at the Vrije Universiteit in Amsterdam, the Netherlands, who was the Principle Investigator for the Phase II study.
Background: Laquinimod is a novel immunomodulatory substance developed as an orally available disease modifying treatment of MS. It is effective in suppressing disease development in experimental animal models of MS. Today, multiple sclerosis (MS) is an incurable disease that results from the body's immune system attacking the myelin sheaths surrounding the nerve fibres in the brain and elsewhere. MS can lead to anything from minor symptoms for lengthy periods to severely incapacitating symptoms within a few years. Initially, MS comes in "flare-ups" with alternating periods of deterioration and improvement. The disease mainly affects young people, and more women than men; the average age of onset of the disease is about 30.
Lund, April 27, 2004
Active Biotech AB (publ)
Sven Andréasson
President & CEO
For further information about Active Biotech visit www.activebiotech.com.
Active Biotech
AB is a biotechnology company focusing on research in and development of pharmaceuticals. Active Biotech has a strong R&D portfolio and pipeline products with focus primarily on autoimmune/inflammatory diseases and cancer. Most advanced projects include orally administered small molecules with unique immunomodulatory properties that can be used to treat autoimmune and inflammatory diseases (SAIK-MS), as well as a novel concept for use in cancer immunotherapy (TTS).
Active Biotech AB
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 20 50