18-03-2011: Adocia, a privately-held biotechnology company specialized in regenerative medicine and in the treatment of chronic diseases, announced positive results from its phase I clinical study evaluating the safety and clinical utility of HinsBet(R), its fast-acting human insulin product for the treatment of diabetes.
The trial compared the product candidate, HinsBet(R), to NovoLog(R) (Novo Nordisk), a fast-acting insulin analog, and Actrapid(R) (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(R) 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(R) is as short as NovoLog(R)’s and shorter than that of Actrapid(R). This was demonstrated by insulin profile and glucose infusion rate profile. Moreover, the inter-patient variability on glycemic control with HinsBet(R) was statistically lower than with NovoLog(R) or Actrapid(R).
HinsBet(R) is a formulation comprising human insulin and one polymer of the BioChaperone(R) platform patented by Adocia. Adocia specifically designed this polymer to form a molecular complex with human insulin to accelerate insulin blood penetration.
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(R) in comparison to NovoLog(R). The company plans to leverage the results of its HinsBet development by partnering with a company involved in the diabetic field.
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Adocia SAS announced the launch of its second clinical trial for the development of HinsBet(R), its fast-acting human insulin.The company completed a Phase I study in March on healthy volunteers showing that the action of HinsBet(R) is as fast as that of NovoLog(R) and has less variability. ... more