Adocia, a privately-held biotechnology company specialized in regenerative medicine and in the treatment of chronic diseases, announced today 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.
Adocia’s BioChaperone platform is a library of polysaccharides modified with naturally occurring molecules. These polymers are designed to form a reversible molecular complex with therapeutic proteins in order to solubilize and stabilize these proteins and to control their delivery.
Adocia already has a clinical development in Phase IIa in India. This is a unique formulation of PDGF-BB with BioChaperone for the treatment of patients suffering from diabetic foot ulcer. This clinical trial is comparing BioChaperone formulation, applied once every two days, to Regranex applied every day. The enrollment of 147 patients has been achieved and the results are expected in the third quarter 2011.