Tag: ITP

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 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 closes C round, receives grant

Munich-based biotech company SuppreMol this month announced the closing of a EUR15.5 M C round as well as receiving a EUR1.6 M public research grant.

The money will be used for the GMP production and further clinical studies of its lead candidate SM101, a recombinant, soluble, non-glycosylated version of the Fc gamma receptor IIb. SM101, which has been granted orphan drug designation in the European Union and in the US, has already entered Phase Ib/IIa clinical studies in Primary Immune Thrombocytopenia (ITP), with interim results anticipated for next year. In addition, the company plans to initiate a Phase IIa study in Systemic Lupus Erythematosus (SLE) mid next year.

Moreover, SuppreMol will explore the therapeutic potential of  SM101 in Lupus Nephritis, a subcategory of this autoimmune disease affecting primarily the kidneys, and evaluate the compound in animal models for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Last not least, the funds will be used for the preclinical development of an anti-FcgRIIb monoclonal antibody, which, due to the different properties of this molecule compared to SM101, may have beneficial therapeutic potential in certain autoimmune diseases.

The C round was led by MIG AG with BioMedPartners AG  as co-lead. The other existing investors Santo Holding GmbH, KfW Mittelstandsbank, Bayern Kapital GmbH and Max-Planck-Gesellschaft also participated in the round which was joined by FCP Biotech Holding GmbH as new investor.