Ipsen says subcutaneous, sustained-release BIM 51077 combination may be effective

By Elaine Rigoli

Tampa, Fla., June 12 - Ipsen released positive results of two BIM 51077 studies, a phase 2 study conducted over a seven-day period then extended to 28 days of treatment and preclinical studies for sustained-release formulations.

Consequently, Ipsen said phase 1 clinical trials are ongoing in diabetic patients to demonstrate the suitability of a sustained-release formulation for subcutaneous administration every one or two weeks with the goal of ultimately providing a ready-to-use, user-friendly, self-administration solution for patients.

The phase 2 results showed that BIM 51077 administered by continuous subcutaneous infusion over seven days was well-tolerated, with a linear pharmacokinetic dose-response relationship and led to expected pharmacodynamic responses such as notable decreases in blood glucose and glucagon levels and increases in insulin concentrations, according to a news release.

The results also showed that BIM 51077 administered in type 2 diabetic patients over 28 days was well-tolerated and achieved marked and sustained improvements in diabetes control.

The preclinical results showed that sustained-release formulations of BIM 51077 injected subcutaneously demonstrated a sustained-release profile with a very low burst and long duration of release that made these formulations suitable candidates to be tested in humans.

Ipsen is a Paris-based pharmaceutical company.

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