11 April 2002
Active Biotech AB (publ)
President & CEO
Active Biotech is developing a new drug in tablet form, SAIK-MS, for the treatment of Multiple Sclerosis (MS). The Phase II clinical study has now been initiated according to plan, and the first patients in Sweden are enrolled in the study.
The objective is to demonstrate that SAIK-MS reduces the progression of MS related brain lesions in patients suffering from relapsing MS (the form of the disease that progresses in flares), and to show that the progression of the disease is slowed down.
The Phase II study of SAIK-MS is a multicentre study and is planned to include several leading MS specialists (neurologists) and other staff at a total of 20 hospitals in the UK, the Netherlands, Russia and Sweden. It is a randomised, double blind, 3-arm, placebo-controlled study. This means that three parallel treatment groups are included, whereby neither patients nor others involved in the study are aware of which treatment group the respective patient belongs to. All information is encoded and is not disclosed until the completion of the study, when the statistical evaluation is performed.
The study will start with a 4-week period during which no active treatment is administered. The patients will then be treated for 24 weeks, receiving doses of 0.1mg or 0.3 mg per day in tablet form. A third group will receive placebo treatment (tablets without the active substance). After the treatment period, there will be an 8-week follow-up period. A total of 180 patients are to be included in the study, each treatment group will include 60 patients. The recruitment of patients is planned to be completed by early autumn 2002. The study duration will be approx. 18 months.
The study will be evaluated with the help of frequent MRI exams (Magnetic Resonance Imaging) to study disease-related changes in patient brain tissue. In addition, a clinical evaluation will be performed based on the degree of handicap as defined by specific protocols (so-called EDSS/MSFC scores).
Professor Chris Polman from the VU Medical Centre in Amsterdam in the Netherlands, whose extensive merits include a large number of different research projects within the field of MS, is the Principal Investigator of the study. The MRI evaluation will be led by Frederik Barkhof, Professor of Neuroradiology and Senior Researcher at the MS-MRI Research Centre. He is also Director of the Image Analysis Centre (IAC) and like Professor Polman, he works at the VU Medical Centre in Amsterdam. Both Professor Polman and Professor Barkhof will have a significant contribution to the performance and upcoming scientific evaluation of the study.
Multiple Sclerosis (MS) is currently an incurable disease, in the course of which the body’s immune system attacks the myelin sheaths surrounding the nerves, including those in the brain. This disrupts nerve impulses or interrupts them completely so that sensory input fails to reach the brain for processing. This means that the brain can no longer communicate with the muscles in the body. MS can lead to anything from mild symptoms lasting for long periods to severe problems that entail serious handicaps within a couple of years. Initially, MS often follows an intermittent or episodic course, with periods of stability between the flares. The disease mainly affects young people and the average age of patients when the disease manifests itself for the first time is around 30. More women than men suffer from MS, which is a chronic autoimmune disease.
Active Biotech’s unique MS drug, SAIK-MS, is assumed to have a new active mechanism. The product is therefore expected to lead to better treatment results compared with currently available drugs. The product also has the major advantage of being administered in tablet form, as opposed to treatments that take the form of injections.