57-57 – a high medical need for treatment of SLE
Active Biotech’s 57-57 project is developing a drug for the oral treatment of systemic lupus erythematosus, SLE.
SLE
SLE – Systemic Lupus Erythematosus – is a life-threatening autoimmune disease that develops in flare-ups interspersed with periods that are relatively free from symptoms. SLE causes inflammation and damage to the connective tissue of many organs in the body. The autoimmune attacks affect many organ systems. The disease may eventually lead to life-threatening secondary disease manifestations, such as renal failure, cardiac disease, arthritis or CNS symptoms. There is no disease modifying product available for treatment of SLE, instead current treatment modalities are immune suppressive and focus on treating the symptoms of the disease rather than the underlying cause. Without treatment, SLE can be life-threatening.
SLE is widespread throughout the world, but is two to three times more common among persons of African, Asian or Latin origin. SLE is most prevalent among women of child-bearing age. The number of patients is increasing and no new drug has been registered since the 1960s, when cortisone and the use of other immunosuppressive drugs were introduced. The medications currently used for treatment of SLE are nonsteroidal anti-inflammatory drugs (“NSAID”), malaria medicines, acetylsalicylic acid, cortisone and cytostatic drugs, such as cyclophosphamide and methotrexate.
There is a major medical need for new treatments for SLE. Active Biotech estimates that at least 500,000 patients each in the US and Europe suffer from SLE. The US organization “Lupus Foundation of America” (www.lupus.org) has estimated that each person with SLE treated in the US costs on average USD 6,000 – 10,000 per year. Accordingly, the market potential for the indication targeted by the 57-57 project can conservatively be estimated at USD 6 billion.
For further information regarding SLE, please visit Lupus Foundation of America at www.lupus.org.
Current results
In June 2009 Active Biotech presented updated data from a concluded Phase Ib trial of the 57-57 SLE project at the 10th Annual Congress of the European League against Rheumatism (EULAR), an international event for specialists in the field of rheumatology.
The patients in the Phase Ib trial were treated daily for 12 weeks with 57-57. The maximum tolerable dose (MTD) was, as earlier communicated, defined at 4.5 mg/day. The overall safety profile throughout the study was favorable.
In a subset of patients treated with 4.5 mg/day 57-57 the global gene expression pattern was investigated after various treatment periods. New results strengthen previous data which indicated that treatment with 57-57 could normalize pathways known to be important in SLE pathogenesis.