SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).
Already, SM101 has successfully completed a Phase Ia trial in 48 healthy volunteers without observation of any SM101-associated adverse reactions. In April 2010, SM101 entered a multi-centric, randomized, double-blind, placebo-controlled, Phase Ib/IIa dose escalating study. In the Phase Ib, up to 36 patients will receive repeated intravenous doses of SM101 or matching placebo once weekly over a period of four weeks. 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 and doubling of platelet count). 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.
“We now have discussed the subsequent development plan for SM101 in ITP, including the design of a Phase III study,” said Sascha Tillmanns, Medical Director of SuppreMol. “During the meeting, the FDA has provided very helpful comments on our study protocols. We will now incorporate the FDA’s recommendations and are very confident that we can meet our planned development schedule.”