Ipsen said that BIM 23A760 has been designed and developed by its research team using its validated peptide engineering platform. The chimeric compound bears within a single molecule two pharmacological moieties, i.e., a somatostatin analog and a dopamine agonist which act synergistically following activation of those receptors in disorders such as acromegaly and neuroendocrine tumors.
Reportedly, the clinical trial is a Phase II open, randomised, parallel group, non comparative multicenter study to assess the efficacy and safety of repeated subcutaneous (sc) administration of different doses of BIM 23A760 on growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels in patients with acromegaly after 6 months of treatment.
Ipsen said that the clinical trial follows Phase I and IIa trials. In the Phase I, BIM 23A760 administration in healthy volunteers potently suppressed prolactin levels and statistically significant reductions in IGF-1 levels were observed.
In the Phase IIa study, the exposure to BIM 23A760 in acromegalic patients, exhibited a 66–74% mean maximum reduction in growth hormone (GH) levels. A dose dependent tendency for a more pronounced and longer GH inhibition was also observed. Additionally, a reduction in IGF-1 levels was seen in both dosage (1mg and 4mg). BIM 23A760 was well tolerated at both dosages.
Stephane Thiroloix, executive vice-president of corporate development at Ipsen, said: “After the encouraging signs of efficacy observed in the first clinical studies in healthy as well as acromegalic volunteers, we look forward to further investigating BIM 23A760 efficacy and safety in patients with neuroendocrine tumors or acromegaly.
“This very promising compound is core to Ipsen’s strategy to enhance its fast-growing and competitive endocrinology franchise, featuring among other drugs Somatuline, a somatostatin analogue developed and marketed on a global scale.”