Ipsen Presents Positive Results For Phase I, Phase IIa BIM23A760 Studies

Ipsen has announced the results of phase I and phase IIa clinical studies for BIM23A760, designed and developed by its peptide engineering platform. This molecule targets two patho-physiological pathways associated with pituitary tumours: growth hormone and prolactin.

In the phase I trial, the exposure to BIM23A760 in healthy volunteers showed a pharmacokinetic profile consistent with sustained release compatible with a once-weekly dosing. BIM23A760 treatment potently suppressed prolactin levels at all tested doses after single dosing, with a decrease in prolactin sustained for at least 4 weeks after repeated dosing. In addition, significant reductions in IGF-1 levels were observed after repeated dosing.

In the phase IIa study, the exposure to BIM23A760 in acromegalic patients, exhibited a pharmacological activity as evidenced by a 66–74% mean maximum reduction in growth hormone (GH) levels, compared to baseline. Additionally, a reduction in IGF-1 levels was seen in both dosage (1mg and 4mg).

Jacques-Pierre Moreau, executive vice-president and chief scientific officer of Ipsen, said: “The phase I and phase IIa results for BIM23A760 show encouraging signs of efficacy with the markers of bioactivity pointing in the right direction. BIM23A760’s original design might represent a true advance in the therapy of pituitary adenomas. This compound is at the very heart of Ipsen’s endocrinology focus and expertise on homeostasis, namely restoring the hormonal imbalance induced by pituitary disorders.”