Date: 2012-02-28
Type of information: Results
phase: 2a
Announcement: results
Company: Adocia (France)
Product: HinsBet® (fast-acting human insulin)
Action
mechanism: rapid-acting insulin. Adocia has developed HinsBet® using its BioChaperone library of polysaccharides modified with naturally occurring molecules. BioChaperone is designed to form a reversible molecular complex with therapeutic proteins in order to solubilize and stabilize these proteins and to control their delivery.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: This phase IIa study was a single center, double-blinded, randomized, cross-over trial conducted on 20 type 1 diabetic patients under euglycemic clamp procedure. The aim of the study was to compare pharmacokinetics, pharmacodynamics and safety of HinsBet® to the fast-acting insulin analog NovoLog®, after 3 consecutive injections of each study medication to each patient.
Latest
news: * On February 28, 2012, Adocia reported positive phase IIa clinical results on its fast-acting human insulin, HinsBet®: the first clinical results are confirmed on diabetic patients. The main results of this clinical trial are a rapid reduction of glycemia, an excellent local tolerance and an inter-patient and intra-patient variability, all comparable to NovoLog® (Novo Nordisk) * On June 24, 2011, Adocia announced the launch of its second clinical trial for the development of HinsBet®, its fast-acting human insulin. The company completed a Phase 1 study in March on healthy volunteers showing that the action of HinsBet® is as fast as that of NovoLog® and has less variability. The positive clinical results obtained with HinsBet® during the Phase 1 study have permitted to quickly start a second study of Phase 2a on 20 type 1 diabetics. As a result of the promising clinical development, the company is actively seeking pharmaceutical partners in order to develop its innovative insulin formulations.
The hypoglycemic effect of HinsBet® is as rapid as the one of NovoLog®, one of the modern prandial insulins. Furthermore, neither serious adverse event nor clinically significant change in laboratory safety parameters occurred in this study. On local tolerance, HinsBet® was as good as NovoLog®. Finally, the inter and intra patients variabilities of the two medications after 3 consecutive injections are also similar on pharmacological parameters. Before launching a complete development plan, Adocia prepares an optimized formulation of HinsBet® for an additional Phase IIa by Q4 2012.
