September 16, 2003
Source: Sven Andreasson President & CEO Active BioTech
A first analysis of the main parameters in Active Biotech's clinical Phase II study with laquinimod (SAIK-MS) for oral treatment of multiple sclerosis (MS) has shown that the study's primary endpoint was reached. The primary endpoint was to show, with the aid of magnetic resonance imaging (MRI), a statistically significant reduction in the disease activity in patients treated with laquinimod during a six-month period.
An evaluation of the safety and side-effects data shows that the product has a highly advantageous safety profile.
The results indicate that patients treated with 0.3 mg/day of laquinimod showed a statistically significant reduction in MRI activity of 30% compared with patients who received a non-active substance (placebo). Patients who were treated with 0.1 mg/day of laquinimod also showed a decline in disease activity. However, it was not statistically significant from the placebo group.
Regarding the secondary objectives related to clinical outcome, this preliminary analysis only includes a limited view on the number of exacerbations and on the EDSS clinical score. This analysis indicated that only approximately 25 % of all patients had an exacerbation during the treatment period and that the mean EDSS score remained stable. As expected, due to the short treatment period, a statistically significant difference between the different treatment groups could not be detected.
An in-depth analysis of all parameters is under way and a complete report will be presented on 6 November at IVA (Royal Academy of Engineering Sciences) in Stockholm, in conjunction with a capital market day on the same date. An invitation will be forwarded separately.
The study, which comprises slightly more than 200 patients at some 20 clinics in Sweden, the UK, the Netherlands and Russia, was carried out under the leadership of Professor Chris Polman at the VU Medical Centre in Amsterdam, in the Netherlands. The MRI work was carried out under the leadership of Frederik Barkhof, Professor of Neuroradiology and Senior Researcher at the MS-MRI Research Centre and Director of the Image Analysis Centre (IAC) in Amsterdam. The study is a randomised, placebo-controlled three-arm study, that is, with three parallel treatment groups in which no one knows to which group the patient belongs until the code is broken after the study is completed.
The patients received treatment daily for six months, 0.1 or 0.3 mg of active substance alternatively a placebo -- all in tablet form. After completion of the treatment period, the patients were monitored for another two months without treatment. In addition to frequent measurement of active inflammation of the brain using X-ray imaging, so-called MRI (Magnetic Resonance Imaging), the number of flare-ups and the time until the first flare-up were also measured. Moreover, clinical evaluations were made applying quantitative assessment scales (EDSS and MSFC) based on the patient's degree of disability.
Multiple Sclerosis (MS) is a neurological, currently incurable disease, in which the body's own immune system attacks the myelin sheaths surrounding nerve fibres in the brain among other areas. The nerve impulses are disrupted or broken and sensory impressions no longer reach the brain so that they can be felt. The brain can no longer communicate with the muscles in the body. MS can result in everything from minor problems over lengthy periods to major disabling symptoms within a couple of years. The disease mainly affects young people and more women than men. The average debut age is about 30. Today, approximately 1 million people worldwide are inflicted with MS.
In addition to its favourable safety profile, a major advantage of Active Biotech's substance laquinimod (SAIK-MS) is that it is administered in tablet form. All currently available treatment alternatives are administered by frequent injections once to three times a week. The injections often result in inflammatory discomfort around the injection site as well as other side-effects, such as symptoms similar to influenza. Laquinimod (SAIK-MS) is potentially the first drug in tablet form for treatment of MS.
The total market for MS drugs amounted to USD 2.8 billion in 2002, distributed among Avonex from Biogen, Copaxone from Teva, Betaseron from Schering and Rebif from Serono. In 2003, sales are projected to increase by 17% to USD 3.3 billion. (Source: SG Cowen, Pharmaceutical Therapeutic Categories Outlook, March 2003).
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, as well as a novel concept
for use in cancer immunotherapy.
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