Date: 2013-04-03
Type of information:
phase: 2a
Announcement: results
Company: Aspireo Pharmaceuticals (Israel)
Product: somatoprim (DG3173 - somatostatin analogue)
Action mechanism: Somatoprim (DG3173) is a novel and proprietary somatostatin analogue (SSA) that is based on a novel amino acid composition and a unique backbone cyclisation technology used for stabilisation of the peptide. During extensive pre-clinical testing, 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 demonstrated 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.
Disease: acromegaly
Therapeutic area: Rare diseases - Hormonal diseases - Endocrine diseases
Country:
Trial
details: 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.
Latest
news: * On April 3, 2013, Aspireo Pharmaceuticals, an Israeli biopharmaceutical company, focused on the development of somatoprim, a novel somatostatin analog (SSA), has announced results of a phase IIa study in acromegaly patients. The study was designed to investigate the safety, tolerability and efficacy of single ascending doses of somatoprim (DG3173) in up to 20 treatment-naïve acromegaly patients. Analysis of the results shows that Somatoprim demonstrated a dose-dependent effect on lowering excess growth hormone (hGH) on treatment-naïve patients suffering from acromegaly. No serious adverse events were reported and the reported adverse events were mild to moderate and of transient nature.
* On November 6, 2012, Aspireo Pharmaceuticals Limited has announced that the first patient has been enrolled in a phase IIa study in acromegaly patients. 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. Initial data from this study is expected to be available in the first quarter of 2013.
