Date: 2012-02-14
Type of information: Interim results
phase: 1b-2a
Announcement: interim results
Company: SuppreMol (Germany)
Product: SM101
Action
mechanism: 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.
Disease: Primary Immune Thrombocytopenia
Therapeutic area: Autoimmune diseases
Country:
Trial
details: The Phase Ib section of this randomized, double-blind, placebo-controlled, dose escalating, multi-centric trial enrolled 36 patients that received up to 12 mg/kg intravenous doses of SM101 as weekly administrations for 4 weeks.
Latest
news: SuppreMol has announced interim results of the Phase Ib/IIa clinical trial of SM101 to treat Primary Immune Thrombocytopenia (ITP). SM101 was safe and very well tolerated with encouraging efficacy data. These data also verify findings from the earlier Phase Ia trial in 48 healthy volunteers that did not report any dose limiting toxicity of SM101. The study showed a dose dependent platelet increase confirming the first therapeutic activity of SM101 in humans.
In the highest dosage group the increase of platelet level continued throughout the three month follow up period. No ITP rescue treatment was necessary in these patients.
SuppreMol intends to report full Phase Ib data at a scientific conference later in 2012.
