Confirmed favorable safety profile for Active Biotech's oral MS drug
The aim of the study was to investigate the safety of orally administered laquinimod at a higher dose (0.9 mg/day) than the dose previously shown to be effective in reducing the number of active brain lesions (0.3 mg/day) (Polman et al. Neurology 2005;64:987-991).
Overall, laquinimod showed a favorable safety profile. The majority of observed adverse events (AEs) were mild or moderate and transient. All patients remained clinically stable or improved in disability and the majority (77%) remained relapse-free during the treatment period.
A total of 22 patients, representing a broad spectrum of MS patients (EDSS 0-6.5), were included in this 48-week study of laquinimod at 0.9 mg/day given orally with an option for dose reduction to 0.6 mg/day. Seventeen patients completed the 48-week treatment period on the original dose of 0.9 mg/day. Three patients discontinued treatment during the course of the study due to mild to moderate adverse events or withdrawn consent. The dose level in two patients was reduced early on to 0.6 mg/day due to abdominal pain or vomiting and remained at this dose level throughout the study. Two serious adverse events (SAE) were reported, both considered unrelated to study medication.
Laquinimod is a novel orally administered immunomodulatory compound developed as a disease modifying treatment in multiple sclerosis (MS). Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries Ltd in 2004. Laquinimod has the potential to be the first available orally-administered disease modifying treatment for multiple sclerosis.
Lund, September 27, 2005
Active Biotech AB (publ)
President & CEO
For further information, please contact:
Sven Andréasson, President & CEO, tel: +46 46-19 20 49
Tomas Leanderson, CSO tel: +46 46-19 20 95
Cecilia Hofvander, Manager Corporate Communication, tel: +46 46-19 11 22
Active Biotech AB is a biotechnology company focusing on research and development of pharmaceuticals. Active Biotech has a strong R&D portfolio with pipeline products focused on autoimmune/inflammatory diseases and cancer. Most advanced projects are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer immunotherapy with the primary indication non-small cell lung cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer 57-57 for SLE and RhuDex® for RA.
Active Biotech AB
Box 724, SE-220 07 Lund
Tel: +46 46-19 20 00
Fax: +46 46-19 20 50