A spireo Pharmaceuticals Limited, an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), reported results of an interim analysis of a Phase Ib 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.
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鈥檚 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.
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.
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