Adocia Reports Positive Phase I Clinical Results on HinsBet®, a Fast-Acting Human Insulin
News Mar 16, 2011
Adocia, has announced positive results from its phase I clinical study evaluating the safety and clinical utility of HinsBet®, its fast-acting human insulin product for the treatment of diabetes.
The trial compared the product candidate, HinsBet®, to NovoLog® (Novo Nordisk), a fast-acting insulin analog, and Actrapid® (Novo Nordisk), a regular human insulin. It was a double blind study involving 12 healthy volunteers. The pharmacokinetic and pharmacodynamic profiles were obtained using the glucose clamp technique.
On the primary endpoint of safety, HinsBet® showed identical results to the commercial products tested, giving excellent local tolerance and absence of pain at the site of injection.
The onset of action of HinsBet® is as short as NovoLog®’s and shorter than that of Actrapid®. This was demonstrated by insulin profile and glucose infusion rate profile. Moreover, the inter-patient variability on glycemic control with HinsBet® was statistically lower than with NovoLog® or Actrapid®.
HinsBet® is a formulation comprising human insulin and one polymer of the BioChaperone® platform patented by Adocia. Adocia specifically designed this polymer to form a molecular complex with human insulin to accelerate insulin blood penetration.
“We think that we have a unique human insulin formulation which could be a best-in-class insulin product, offering type 1 and 2 diabetics a performance on glycemia control as high as insulin analogs but in a more cost-effective way and with less variability,” said Dr Gérard Soula, Adocia’s President and CEO.
“This fast-acting human insulin fulfills all requirements of FDA and EMA for insulin products and is easily injected with all insulin devices,” said Dr Olivier Soula, Vice President of Adocia and R&D Director. “This is the first completed human study which shows the potential of Adocia’s BioChaperone® as a radically new way of delivering therapeutic proteins.”
Following the results of this phase I trial, Adocia is preparing a phase IIa study on type 1 diabetics to confirm the fast onset of action and the reduction of variability of HinsBet® in comparison to NovoLog®. The company plans to leverage the results of its HinsBet development by partnering with a company involved in the diabetic field.