Date: 2014-04-22
Type of information:
phase: 1b
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:
Latest
news: * On April 22, 2014, Aspireo Pharmaceuticals, an Israeli biopharmaceutical company, focused on the development of Somatoprim (DG3173), a novel somatostatin analog (SSA), has reported final data from a further phase Ib study in healthy volunteers. In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control. The main purpose of the study was to investigate the effects of each treatment on the control of plasma glucose as well as the secretion of insulin and glucagon following a standard meal. The final data demonstrate that octreotide significantly inhibits the secretion of insulin and glucagon in humans and shows a significant and sustained increase of plasma glucose levels. In contrast, DG3173 has much less of an effect on insulin and glucagon release compared to octreotide, as well as the normalization of glucose control. This improved profile was observed even at high doses of DG3173. Carsten Dehning, CEO of Aspireo Pharmaceuticals said: ”This study clearly demonstrates the superiority in the side effect profile of DG3173 over octreotide. These results confirm the findings from pre-clinical studies and support the unique profile of this promising investigational drug with respect to glycaemic control.” * On January 7, 2013, Aspireo Pharmaceuticals has 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. A phase 2a study is currently ongoing in acromegaly patients. In November 2012, Aspireo has announced that the first patient has been enrolled.
