Munich, Germany, September 09, 2014: SuppreMol GmbH, a biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced that an abstract detailing phase IIa clinical data of SM101 in SLE patients has been accepted for presentation at the 2014 ACR / ARHP Annual Meeting, to be held in Boston, Massachusetts, USA on 14 - 19 November 2014.
The abstract "SM101, a Novel Recombinant, Soluble, Human FcyIIB Receptor, in the Treatment of Systemic Lupus Erythematosus: Results of a Double-Blind, Placebo-Controlled Multicenter Study" will be presented in the session "Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Novel Therapies for Systemic Lupus Erythematosus" on Tuesday, November 18 at 2:30 PM EST (Presentation Number 2787).
The phase IIa clinical trial enrolled 51 SLE patients for six months. Patients received 6 mg/kg or 12 mg/kg SM101 or placebo and randomized to a ratio of 2:2:1. The clinically relevant endpoints were SLEDAI, BILAG, PGA and Overall Response, equivalent to the Responder Index. SM101 showed a clear numerical dose response in all four key endpoints at six months. SM101 confirmed its excellent safety profile in this clinical trial.
Mike Tansey, Chief Development Officer at SuppreMol commented: "We are very excited by the promising therapeutic activity and excellent safety profile seen in this first SLE trial with SM101. Acceptance of our encouraging data for oral presentation by the ACR/ARHP Annual Meeting and the positive response we have received from our clinical advisors provide a further incentive for us to continue the expeditious development of SM101 to help patients suffering from SLE."
About SM101
SuppreMol's lead candidate SM101 is a recombinant, soluble, non-glycosylated version of the Fc-gamma-receptor IIB (sFcyIIB). The protein binds to autoantibody/autoantigen complexes and blocks the activation of Fc receptors on the surface of immune cells. As a result, the immune response is down regulated as is the associated inflammation cascade, typically observed in autoimmune diseases. The efficacy of SM101, including a reduction of inflammation and immune parameters, has been demonstrated in relevant animal models. At present, SM101 is being evaluated in Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE). SM101 has received orphan drug designation in the US and Europe for ITP. SM101 also has potential in a number of other B cell driven autoimmune diseases, including Rheumatoid Arthritis (RA).
About SuppreMol
SuppreMol GmbH is a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune and allergic diseases. The company is pioneering the development of soluble Fc-gamma receptors (sFcyRs), which are recombinant autologous therapeutic proteins with a specific immunoregulatory potential. The company is developing FcyRs for the treatment of Primary Immune Thrombocytopenia (ITP), Systemic Lupus Erythematosus (SLE) and potentially for Rheumatoid Arthritis (RA) and other autoimmune conditions. SuppreMol's pipeline includes two antibody development programs utilizing the inhibitory effect of FcyRIIB suitable for alternative treatment strategies and indications.
Contact
SuppreMol GmbH
Dr. Klaus Schollmeier
Chief Executive Officer
Tel: +49 89 30 90 50 680
E-mail: info@suppremol.com
www.suppremol.com
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