Aspireo Pharmaceuticals Limited, has announced that the first patient has been enrolled in a phase IIa study in acromegaly patients.
The study is designed to investigate the safety, tolerability and efficacy of Somatoprim (DG3173) in untreated acromegaly patients.
Up to 20 patients 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.
Carsten Dehning, CEO of Aspireo said: "Based on extensive preclinical and early clinical profiling Somatoprim has demonstrated the potential to become best-in-class somatostatin analog due to improved safety and efficacy. 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, the current market leading SSA. These data, together with data which is currently being gathered in a phase Ib multi-ascending-dose clinical study in healthy volunteers will form the basis for further clinical development and is expected to provide a clear path towards approval."
Initial data from this study is expected to be available in the first quarter of 2013.