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news.SuliXen remains in circulation up to 20-30 hours
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Lipoxen, a biopharmaceutical company, has announced positive results from its completed Phase I trial of SuliXen, its long-acting insulin candidate for type 1 and type 2 diabetes.
The Phase I cross-over study, which took place at the Federal State Center of Endocrinology in Moscow, Russia, involved 12 healthy volunteers, each receiving two doses of SuliXen (0.1 IU/kg and 0.3 IU/kg) as well as one dose of insulin glargine (Lantus, Sanofi-Aventis) dosed at 0.2 IU/kg. This dosing regime was designed to allow a comparison with this commercially successful long-acting, insulin analog, the company said. The data set covers all of the treatments received by the 12 healthy volunteers taking part in the study.
Acording to Lipoxen, the study showed that both Sulixen, at both dosing levels, and insulin glargine, were well tolerated with no adverse events being observed during the Phase I trial.
The trial also provided data on SuliXen’s pharmacodynamics. In the study (which involved 36 euglycemic hyperinsulinemic clamps), those who received SuliXen dosing of 0.1 IU/kg or 0.3 IU/kg and insulin glargine dosed at 0.2 IU/kg showed a clear pharmacodynamic response, as demonstrated by the increased glucose infusion rate (GIR). Importantly, the SuliXen treated patients showed no significant peaks in GIR within the observation period of the study suggesting a peak-less profile for Sulixen.
The trial also showed that SuliXen both at 0.1 IU/kg or 0.3 IU/kg was more potent than Lantus at 0.2 IU/kg. SuliXen has favorable pharmacokinetic profile, reaching maximum blood concentrations within three hours after subcutaneous injection and remaining in circulation up to 20-30 hours, depending from the dose injected. This was confirmed using an insulin immunoassay to measure insulin serum levels, the company said.
Scott Maguire, CEO of Lipoxen, said: The SuliXen data shows that we are well on our way to developing a safe and novel insulin formulation that may well be more efficacious and provide a reduced dosing regime to currently marketed insulin products. This would make SuliXen an important new entrant into the $13 billion insulin market.