Tag: Idiopathic Thrombocytopenic Purpura

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.

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.

Company News: SuppreMol Initiates Phase Ib/IIa Clinical Trial With Its Lead Candidate SM101

SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced the initiation of a Phase Ib/IIa clinical trial with its lead product SM101 in Idiopathic Thrombocytopenic Purpura (ITP) in Europe. For further details on the trial and the compound, please see the complete press release.

In a Phase Ia trial in 48 healthy volunteers started in April 2009, no SM101-associated adverse reactions have been observed. Detailed results of this study will be published soon.