SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases and allergies, announced the start of dosing in the context of the international SMILE study (SM101 In lupus erythematosus). The Phase 2a, double-blind clinical trial of SM101, the lead compound of the company, involves patients suffering from systemic lupus erythematosus (SLE).

The first patient was treated last month in Australia. Additional study centers in Belgium, Germany, France, Great Britain, Italy, the Netherlands, Poland, Spain, and the Czech Republic will commence patient treatment in the coming weeks. Over the course of one month, the study participants will receive placebo or two different doses of SM101 weekly.

“Enrolling the first patient into the SMILE study is another important milestone for SuppreMol,” says Peter Buckel, the company’s CEO. “SLE, along with other conditions such as rheumatoid arthritis and multiple sclerosis, is an autoimmune disease for which no effective treatment options are available. The current standard therapies either just treat symptoms or are associated with a considerable risk of complications. Our approach focuses on the initial phase of the autoimmune reaction and offers the potential of sustained therapeutic benefit without severe side effects.”

SM101 is a soluble version of the Fc gamma receptor IIb, which binds to autoantibody/autoantigen complexes and thereby blocks the triggering of Fc receptors on the surface of immune cells.  SM101 has been studied in the context of a clinical Phase 1b/2a trial for the indication of primary immune thrombocytopenia (ITP) since 2010. For this indication, the product is designated as a drug for rare medical conditions (orphan drug) in the European Union and in the United States.

Date: November 29, 2011
Source: SuppreMol GmbH