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SuppreMol initiates Phase IIa clinical trial in Systemic Lupus Erythematosus (SLE) with its ...

SuppreMol initiates Phase IIa clinical trial in Systemic Lupus Erythematosus (SLE) with its lead candidate SM101

Martinsried/Munich, Germany, July 11, 2011 -- 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.

'We are very happy to be on track with our planned clinical trials”, said Peter Buckel, CEO of SuppreMol. 'This study represents the evaluation of SM101 in the first rheumatic disease indication, a huge market with high unmet medical need. Standard SLE therapies target the entire immune system and therefore bear the risk of serious side effects. The recent approval of Benlysta™, the first new Lupus drug in 50 years, is certainly a breakthrough in this market. However, the drug is approved only as an adjuvant to standard therapy and excludes autoantibody-negative SLE patients and patients with severe active Lupus Nephritis or CNS Lupus.”


Notes to Editors

About SuppreMol
SuppreMol is a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases and allergies. The company is pioneering the development of soluble Fc gamma receptors (sFcRs), which are recombinant autologous therapeutic proteins with a proven, strong immunosuppressive potential. The company plans to develop sFcRs for the treatment of Primary Immune Thrombocytopenia (ITP), Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) and other autoimmune conditions. SuppreMol’s pipeline comprises three early antibody development programs against Fc receptor IIb (FcRIIb) suitable for alternative treatment strategies and indications (e.g. hypersensitivities) as well as an anti IL-3 antibody to treat RA for which the company obtained an exclusive license option recently.

SuppreMol was founded in 2002 as a spin-off from the laboratory of Prof. Dr Robert Huber, Nobel Prize for Chemistry in 1988, at the Max Planck Institute for Biochemistry in Martinsried, Germany. The company has raised EUR 35.2 million in three financing rounds since May 2006 and investors include MIG AG, BioMedPartners AG, Santo Holding GmbH, FCP Biotech Holding GmbH as well as KfW Mittelstandsbank, Bayern Kapital GmbH, Max Planck Society, and Z-Cube. SuppreMol received BMBF research grants of over EUR 2 million since 2007.

About SM101
SuppreMol's lead candidate SM101 is a recombinant, soluble, non-glycosylated version of the Fc receptor IIb. The protein binds to autoantibody/autoantigen complexes and blocks the triggering of Fc receptors on the surface of immune cells. As a result, the immune response is downregulated and the activation of the inflammation cascade typically seen in autoimmune diseases is prevented.

SM101 has been validated in relevant animal models and has shown strong efficacy by decreasing inflammation and immune reactions.

At present, SM101 is being developed in Primary Immune Thrombocytopenia (ITP). SuppreMol has been granted orphan medicinal product designation in the EU as well as orphan drug designation in the US for this indication. The company believes SM101 may also have potential in Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) and other autoimmune diseases.

About SLE
Systemic Lupus Erythematosus (SLE) is a complex, chronic autoimmune disorder, which can involve many organs. The disease can be further differentiated by subcategories of SLE including Lupus Nephritis (LN), a kidney disorder associated with more severe SLE, and Cutaneous Lupus Erythematosus (CLE). It is usually a life-long disease, potentially fatal, and characterized by unpredictable flares and remissions. The most commonly affected areas attacked by auto-antibodies are the joints, skin, kidneys, heart, lungs, blood vessels, and the brain. It may develop abruptly or insidiously over a period of months or years with episodes of pain in the joints and general malaise.

Women account for about 90% of patients suffering from SLE, of which are between 15-45 years old, i.e. in child-bearing age. Genetic factors may play a role and certain drugs used to treat other disorders (D-penicillamine, chlorpromazine, certain anticonvulsants, β-blockers, minocycline) can trigger the symptoms of SLE (“drug-induced” SLE), which may disappear when treatment ends. Environmental factors, including various chemicals and chemical solvents such as paint removers, chlorinated solvents and silica are also believed to be associated with the onset of the disease.

The 10-year survival rate is over 85%. However, this rate is lower for patients whose vital organs (brain, lungs, heart or kidneys) are affected.

Prof. Dr. Peter Buckel, CEO
SuppreMol GmbH
Am Klopferspitz 19
D-82152 Martinsried-Munich / Germany
Tel +49 (0)89 30 90 50 680
Fax +49 (0)89 30 90 50 68 68

Publisher Contact Information:

+49 (0)89 30 90 50 680

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