Tag: SM101

Company News: SuppreMol Starts SM101 Dosing in the Context of SMILE Study

Australian study center treats first systemic lupus erythematosus (SLE) patients –

SuppreMol GmbH today announced the start of dosing in the context of the international SMILE study (SM101 In Lupus Erythematosus). The phase IIa, 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.

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 Ib/IIa 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.

Company News: SuppreMol Employs Protagen Biomarkers in SLE Study

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases and allergies, and Protagen AG, a specialist in in-vitro diagnostics and GMP-compliant protein analysis, today announced a collaboration to identify therapy-related biomarkers in patients with Systemic Lupus Erythematosus (SLE).

SuppreMol will use the biomarkers for the rapid identification of autoantibody signatures in the serum of SLE patients enrolled in the current phase IIa study of its lead product SM101. Thereby, the company hopes to identify patients who are most likely to respond favorable to SM101. Since SLE is a disease with very diverse manifestations, the findings may also allow for the classification of patients into subgroups .

Financial details of the collaboration are not disclosed. The cooperation as well as SuppreMol’s phase IIa SLE study are supported by the German Federal Ministry for Education and Research (BMBF) as part of the Leading Edge Cluster m4.

Company News: SuppreMol Initiates Phase IIa Clinical Trial in Systemic Lupus Erythematosus (SLE) With Its Lead Candidate SM101

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases and allergies, today announced the initiation of a Phase IIa clinical trial with its lead product SM101 in Systemic Lupus Erythematosus (SLE).

The multi-centric, randomized, double-blind, placebo-controlled, parallel group Phase IIa study will enroll 50 SLE patients with or without a history of Lupus Nephritis and a SELENA-SLEDAI score of ≥ 6 and active serological status. Over four weeks, two groups of twenty patients each will intravenously receive 6 or 12 mg/kg/week of SM101, while 10 patients will receive placebo. 30 clinical sites in Australia, Belgium, the Czech Republic, France, Germany, Italy, Poland, Spain, and the UK will participate.

The primary endpoint of the proof-of-concept trial is safety based on the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE). Further safety endpoints comprise, among others, vital signs, body temperature, body weight, electrocardiogram, safety laboratory assessments, and the occurrence of anti-drug antibodies (ADAs). Efficacy is determined by overall and renal disease score assessments, proteinuria, urine sediment, a number of biochemical, biological and molecular markers, and use of rescue medication. Results of the trial are expected for 2013.

SM101 already has been shown to have an excellent safety and tolerability profile as well as favorable pharmacokinetics in a Phase Ia trial in 48 healthy volunteers completed in 2009. Subsequently, a Phase Ib/IIa multi-center clinical trial for the treatment of Primary Immune Thrombocytopenia (ITP) was started in early 2010.

Company News: SuppreMol Receives U.S. Orphan Drug Designation for SM101

SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced that the FDA’s Office of Orphan Products Development has granted Orphan Drug Designation (ODD) for SuppreMol’s lead product SM101, a recombinant human soluble Fcγ receptor IIb, for the treatment of Idiopathic Thrombocytopenic Purpura (ITP).

At present, SM101 is in a Phase Ib/IIa clinical study in ITP, with results expected in early 2011. For the same indication, the molecule has already been granted Orphan Medicinal Product Designation in Europe by the EU Commission in 2007. Further details are available on the company’s website.