The trial is designed as a mono-centric, randomized, double-blind, placebo-controlled study, which is conducted in Germany. About 42 male human volunteers between 18 and 40 years will receive SM101 or matching placebo intravenously as single ascending dose. Primary endpoints are safety and tolerability, while the pharmacokinetics profile of SM101 will be assessed as a secondary endpoint.
"This is the first clinical trial for our company, and we are very much looking forward to the results," said Peter Buckel, CEO of SuppreMol. "If the data are as expected, we are planning to start a Phase Ib/IIa clinical trial with SM101 in patients by the end of this year."
"The first indication we are addressing is Idiopathic Thrombocytopenic Purpura, a disease of unknown causes characterized by a low count of thrombocytes, which can lead to frequent bruises or, more seriously, to excessive and life-threatening bleeding," added Sascha Tillmanns, Medical Director of SuppreMol.
SM101 is a recombinant human soluble version of an immune receptor with a unique mode of action. It is developed by SuppreMol for the treatment of autoimmune diseases such as Idiopathic Thrombocytopenic Purpura (ITP), Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). Last year, the European Commission granted SuppreMol orphan medicinal product designation in the EU for SM101 in ITP.
About SM101
SuppreMol's lead product SM101 is a recombinant, soluble, non-glycosylated version of the Fc-receptor Fc?RIIb. It 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 a short half-life and the patient's immune competence is restored once the compound is washed out of the circulation. Moreover, non-target B-cells (i.e., B-cells participating in regular immune reactions) are not affected, so that possible side-effects such as increased susceptibility to infections are not expected.
SM101 has been validated in relevant animal models and has shown strong efficacy in terms of decrease in inflammation and immune reaction.
About SuppreMol
SuppreMol is a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases. The Company is pioneering the development of soluble Fc?-Receptors (sFcRs), which are recombinant autologous therapeutic proteins with a proven strong immunosuppressive potential. The Company plans to develop sFcRs for the treatment of idiopathic thrombocytopenic purpura (ITP), systemic lupus erythematosus, rheumatoid arthritis and other autoimmune conditions.
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 19.7 million in two financing rounds since May 2006 and received a EUR 1,75 million “Innovative Therapeutics” grant from the BMBF in March 2007.
