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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(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.
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).
“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(R) 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(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.
About BioChaperone(R)
Adocia’s BioChaperone(R) 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(R) for the treatment of patients suffering from diabetic foot ulcer.
This clinical trial is comparing BioChaperone(R) 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.
About Adocia SAS (http://www.adocia.com)
Adocia (Lyon, France) is a privately held French biotechnology company specialized in regenerative medicine and in the treatment of chronic diseases. Adocia is developing innovative protein formulations based on its proprietary technology, BioChaperone(R). These include new formulations of BMPs (bone morphogenic proteins) for bone repair and other indications. Adocia is also engaged in two collaborative programs on the formulation of monoclonal antibodies using its BioChaperone(R) platform with two biopharma companies, and it has three collaborations with medtech companies.
For more information, please contact:
Adocia
Nathalie Villot – n.villot@adocia.com
Tel: +33 (0)4.72.61.06.09
