Preliminary Data Analysis Supports Excellent Safety and Side Effect Profile of Somatoprim
Tel Aviv, Israel – 7th January 2013: Aspireo Pharmaceuticals Limited, (“Aspireo”) an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), today 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.
Somatoprim (DG3173) is a novel and proprietary somatostatin analog (SSA) that is based on a novel amino acid composition. Somatoprim has demonstrated a unique receptor binding and pharmacological profile which is significantly differentiated from SSAs that are currently marketed or in clinical development. In particular, Somatoprim has shown an improved side effect profile with reduced adverse effects on the gastrointestinal tract and glucose metabolism. Furthermore, assessment of growth hormone secretion in cultured human somatotroph adenoma tissue treated with Somatoprim indicates that it has the potential to increase the response rate of acromegalic patients to SSA therapy. Somatoprim is currently in phase I/II of clinical development. Somatostatin analogs have been approved for the treatment of acromegaly, carcinoid tumours, and Cushing’s disease but have also demonstrated significant potential in diabetic retinopathy. Somatostatin analogs are generating more than USD 1.5 billion in annual sales in a continually growing market.
Aspireo Pharmaceuticals Ltd is a biopharmaceutical company focused on the development of a novel somatostatin analog (SSA) for the treatment of diseases resulting from hormone-active tumors, such as acromegaly, neuroendocrine and gastroenteropancreatic tumors, Cushing’s Disease and diabetic retinopathy. Aspireo’s sole development compound is Somatoprim (DG3173), a novel and proprietary somatostatin analog that is based on a novel amino acid composition and a unique backbone cyclization technology used for stabilization of the peptide. Aspireo is an Israeli company established in 2010 by TVM Capital as a Project Focused Company (PFC). In September 2012 Aspireo and Evotec AG, Hamburg, Germany, entered into a strategic advisory agreement whereby Evotec will support Aspireo in the partnering of Somatoprim. For additional information please go to www.aspireopharma.com