Aspireo Pharmaceuticals Limited has announced results of an interim analysis of a phase I b study.
This single centre study is investigating the safety, side effect profile, as well as pharmacokinetic and pharmacodynamic profile of multiple ascending doses of Somatoprim in healthy male volunteers, when administered alone and in combination with octreotide.
The preliminary data confirms the excellent safety profile of Somatoprim, with the maximum tolerated dose not reached. No serious adverse events were reported.
The few reported adverse events were generally mild to moderate and transient.
Somatoprim also demonstrated a dose-dependent lowering effect on growth hormone (hGH), as shown by an analysis of the pharmacodynamic effect on hGH, when stimulated by growth hormone releasing hormone.
The interim analysis also supports the beneficial side effect profile of Somatoprim when compared to octreotide.
The company expects final data to be available in Q2 2013.