Adocia Launches Phase IIa Clinical Study on Type 1 Diabetic Patients
News Jun 27, 2011
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. The positive clinical results obtained with HinsBet(R) during the Phase I study have allowed a quick start to a second study of Phase IIa on 20 type 1 diabetics.
The Phase IIa study is double-blinded, under euglycemic clamp, and aims to compare variabilities of HinsBet(R) and NovoLog(R) with three repeated injections of each product to each patient.
“We expect this study to confirm HinsBet(R)’s similar efficacy on type 1 diabetics compared with Novo Nordisk’s fast-acting insulin analog which is the market leader,” said Dr Gérard Soula, president and CEO at Adocia.
Adocia has developed HinsBet(R) using its BioChaperone(R) library of polysaccharides modified with naturally occurring molecules. BioChaperone(R) is designed to form a reversible molecular complex with therapeutic proteins in order to solubilize and stabilize these proteins and to control their delivery.
”Adocia’s BioChaperone boosts absorption of insulins, human as well as analogs,” said Dr Olivier Soula, vice president and R&D director at Adocia. “This has already been proved in the clinic in humans with human insulin. Moreover, the absorption rate with NovoLog(R) has been doubled after subcutaneous injection using a pig model.”
As a result of the promising clinical development, the company is actively seeking pharmaceutical partners in order to develop its innovative insulin formulations.
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