SuppreMol Initiates Phase Ib/Iia Clinical Trial With Its Lead Candidate SM101
4/14/2010 3:27:34 PM
Martinsried/Munich, Germany, April 12, 2010 -- 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).
The first patient in the multi-centric, randomized, double-blind, placebo-controlled, dose escalating study has been enrolled in Poland. In the Phase Ib, up to 36 patients will receive repeated doses of SM101 weekly for four weeks, or matching placebo intravenously. Subsequently, SuppreMol plans to enroll an additional 15 patients to expand the study to a Phase IIa parallel-group clinical trial, which will be conducted in Germany, Belgium, Poland, and Russia.
The primary endpoint is safety based on the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE). The main efficacy endpoint is the proportion of subjects with a substantial platelet response (i.e. more than 30,000 platelets/µl blood). Secondary endpoints comprise number of bleeding events, time to reach platelet response, duration of platelet response, proportion of subjects with rescue medication, and dose reduction of concomitant ITP medication.
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.
"Following the successful completion of the Phase Ia trial in March this year, we are very pleased to expand our clinical studies with our lead molecule SM101," said Peter Buckel, CEO of SuppreMol. "We are looking forward to completing the Phase Ib/IIa trial by December, 2011, and to generate some initial data on the efficacy of SM101 by February, 2011 from phase Ib then."