SuppreMol releases positive interim Phase Ib/IIa results on SM101 in Primary Immune Thrombocytopenia (ITP) trials

Data confirm excellent safety profile and therapeutic activity

16-Feb-2012 - Germany

SuppreMol GmbH 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.

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. SM101 was safe and well tolerated. 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.

'These exciting results provide convincing evidence and reason for SuppreMol to continue with the further development of SM101 in ITP and other B cell driven autoimmune diseases', said Prof. Peter Buckel, CEO of SuppreMol GmbH. 'We are very encouraged by these data that indicate the efficacy of SM101 in humans, especially the long lasting effect on platelet increase that confirms its fascinating therapeutic potential. SM101 continues to work after only one treatment cycle, unlike current treatments for ITP, possibly due to its new mode of action. In particular, SM101 may require a lower dosage frequency than thrombopoietin receptor agonists.'

https://www.bionity.com/en/news/136512/suppremol-releases-positive-interim-phase-ib-iia-results-on-sm101-in-primary-immune-thrombocytopenia-itp-trials.html