SM101 Shows Sustained Clinical Activity
SuppreMol GmbH, a biopharmaceutical company focused on the development of novel therapeutics for the treatment of autoimmune diseases, announced the presentation of interim results from an ongoing Phase 1b/2a clinical trial in ITP patients. In the dose escalation part of the study, patients were treated at dose levels between 0.3 and 12 mg/kg and received 5 injections of SM101 during the 8 week treatment cycle. Three out of four patients treated with 12 mg/kg of SM101 showed a clinically important and sustained increase in platelet count after a single cycle of treatment with SM101. At dose levels of up to 12 mg/kg SM101, no safety concerns have been identified.
"The interim data of SM101 in patients suffering from chronic ITP are very encouraging", comments Dr. Tatyana Semenovna Konstantinova of GUZ Sverdlovskaya Regional Clinical Hospital #1, Yekaterinburg, Russia, a Principal Investigator for the ongoing Phase Ib/IIa study. "The combination of sustained platelet response after a single cycle of SM101 and the favorable safety profile certainly warrants further development of this exciting therapeutic approach."
"Current therapies of chronic ITP all have important limitations", comments Dr. David Kuter from Massachusetts General Hospital, Harvard Medical School, an expert in the treatment of ITP. "SM101 has a novel mechanism of action that is designed to selectively modulate the immune response. Early clinical data presented at ASH suggest that it has the potential to provide a prolonged increase in platelet counts in patients with ITP."
SuppreMol has an ongoing dose-escalation trial in ITP in Europe and intends to initiate a randomized Phase 2 clinical trial in ITP in the US and Europe in 2013.
Date: December 4, 2012
Source: SuppreMol GmbH