Aspireo enrols first patient for Phase IIa study of somatoprim
Aspireo Pharmaceuticals has reported the enrolment of the first patient in a Phase IIa trial designed to investigate the safety, tolerability and efficacy of somatropin (DG3173) in untreated acromegaly patients. Up to 20 individuals are planned to receive ascending single doses of somatoprim and one dose of octreotide, the current gold standard of medical therapy for acromegaly, with each patient receiving all doses of somatoprim as well as octreotide. In September, Aspireo and Evotec entered into a strategic advisory agreement whereby Evotec will support Aspireo in the partnering of somatoprim.
This first Phase II study is designed to demonstrate efficacy in acromegaly patients in terms of reduction of growth hormone levels. Effects on growth hormone levels will also be compared with those of octreotide. Initial data from this study are expected to be available in the first quarter of 2013. These, together with data that are currently being gathered in a Phase Ib multi-ascending-dose study in healthy volunteers, will form the basis for further clinical development and are expected to provide a clear path towards approval. Somatoprim is in Phase I/II development, with a Phase Ib study in Switzerland and a Phase IIa study in the Ukraine, both currently under way.