Insulin issue

Molecular delivery system enhances drug effect in diabetic subjects

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LYON, France—More than 366 million people worldwide suffer from diabetes, and it is projected that the number will grow to 552 million by 2030. Adocia, a biotechnology company specializing in the development of best-in-class medicines with already approved therapeutic proteins, is targeting the $20-billion market with a number of products that are showing positive results in clinical trials.
Adocia’s BioChaperone platform is designed to enhance the effectiveness and safety of therapeutic proteins. The molecular delivery system, based on innovative polymers that have the ability to chaperone therapeutic proteins, appears to reduce the frequency of application, reduce the dose, improve the delivery and increase the efficacy of drugs.
Adocia recently reported positive results from a Phase 2a clinical trial evaluating its ultra-fast formulation of insulin BioChaperone Lispro in comparison to Eli Lilly and Co.’s Humalog commercial insulin. Adocia’s formulation, which incorporates proprietary BioChaperone technology, enables accelerated absorption of prandial (meal-associated) insulins. BioChaperone Lispro is significantly faster than Humalog in type 1 diabetic patients, with an onset of action that is 30 percent earlier and early metabolic effect that is 69 percent stronger, according to the study results.
The ultra-fast action of BioChaperone Lispro should have a positive impact on short- and long-term glycemic control, improving medical benefits for patients, according to the company. BioChaperone Lispro is the third insulin product in Adocia’s portfolio to demonstrate clinical proof of concept in diabetic patients.
“The objective is to control both hyperglycemia and hypoglycemia,” explains Remi Soula, Adocia’s director of development. “We have been working on a method of faster diffusion from the injection site to the bloodstream, so that the insulin action is rapid.”
The present study met its primary endpoint, showing a significant increase in BioChaperone Lispro bioavailability in the first half-hour as compared to Humalog. The company said that this parameter is critical, because the ultimate goal for prandial insulins is an immediate absorption in the blood following subcutaneous injections. This result demonstrates that BioChaperone Lispro more closely mimics the endogenous insulin secretion observed in healthy individuals in response to a meal.
BioChaperone Lispro now has a complete clinical data package ready to support the next clinical trial, a dose-response and dose-exposure study that will be launched this quarter and is to be conducted in Germany. The trial is expected to enroll 36 type 1 diabetic patients under automated euglycemic clamp conditions with three doses of BioChaperone Lispro and one dose of Humalog. Results are expected before the end of 2014.
Prandial insulins are supposed to control the rapid rise in glycemia associated with digesting a meal, according to Soula. Under ideal conditions, the insulin release in the bloodstream would begin immediately after the start of the meal as in normal physiological conditions. Because there is a lag time between the injection and presence of active insulin in the bloodstream even with modern fast-acting insulin analogs, there is a need to inject prandial insulin analogs around 15 minutes before the meal.
Hyperglycemia results from a delay in insulin response compared to glucose entry in the blood flow after a meal. Chronic hyperglycemia is can lead to cardiovascular complications in diabetic patients and represents a major health issue. The earlier onset and higher early bioavailability of BioChaperone Lispro, as compared to Humalog, can reduce the incidence of hyperglycemic events. Hypoglycemia results from an excess of insulin relative to blood glucose concentration. The shorter exposure of BioChaperone Lispro compared to Humalog may also limit the incidence of hypoglycemic events.
“These clinical results demonstrate that BioChaperone Lispro is an ultra-fast-acting insulin that could be used at meal times or even after a meal. Moreover, as a result of its fast-in and fast-out profile, this ultra-fast-acting formulation of insulin Lispro could reduce hyperglycemic and hypoglycemic events, which would be a key benefit for patients with diabetes,” said Dr. Tim Heise, CEO of Profil Neuss, the contract research organization that conducted the study, in a news release about the clinical trial results.
According to Gerard Soula, chairman and CEO of Adocia, “We think our insulin pipeline positions us to become an important player in the insulin field. Our priority is to bring, as rapidly and as efficiently as possible, these innovative treatments to patients. Adocia is now focused on finding the right partners to achieve this.”

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