First Patient Dosed in First Proof-Of-Concept Study in Untreated Acromegaly Patients
Tel Aviv, Israel – 6th November 2012 Aspireo Pharmaceuticals Limited, (“Aspireo”) an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), announced today 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.
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 metabolic control. Furthermore, assessment of growth hormone secretion in cultured human somatotroph adenoma tissue treated with Somatoprim indicates that it has the potential to significantly increase the response rate of acromegalic patients to SSA therapy. Somatoprim is in phase I/II of clinical development with a phase Ib study in Switzerland and a Phase IIa study in the Ukraine, both currently underway. Somatostatin analogs have been approved for the treatment of acromegaly, carcinoid tumours, and Cushing’s disease but also have 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 analogue 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