• BioChaperone Lispro U200, a BioChaperone Lispro formulation at twice the standard insulin concentration, met all pre-specified endpoints, delivering an ultra-rapid profile equivalent to BioChaperone Lispro U100 in an initial pilot study.
• Adocia receives a $10 million milestone payment from Lilly after successful completion of this clinical pilot study.
Lyon and Indianapolis, December 11, 2015 – Adocia (Euronext Paris: ADOC) and Eli Lilly and Company (NYSE: LLY) announced today the successful completion of a preliminary Phase 1 clinical trial evaluating BioChaperone Lispro U200, a concentrated formulation of BioChaperone Lispro, the ultra-rapid formulation of insulin lispro licensed to Lilly. This completed pilot study aimed to determine the potential for bioequivalence of BioChaperone Lispro U200 to BioChaperone Lispro U100 in healthy volunteers.
There is a current trend toward insulin products with a higher concentration, primarily to meet the need for reduced injection volumes. Recently, Lilly’s Humalog® 200 units per mL (U-200), the first concentrated mealtime insulin analog and a new formulation of insulin lispro, was approved and launched in Europe and in the United States. Humalog U200 was established bioequivalent to Humalog 100 units per mL (U-100) in healthy volunteers. However, an ultrarapid version of concentrated insulin may better mimic the physiological timing of prandial insulin action.
“The excellent results of this pilot study are an important milestone in the advancement of the ultra-rapid BioChaperone Lispro development program,” says Olivier Soula, Adocia’s R&D Director and Deputy General Manager. “The ability of BioChaperone technology to accelerate the absorption of insulin lispro at both U100 and U200 concentrations could play an important role in expanding and strengthening the Humalog franchise.”
In this four-period crossover, randomized, double-blind study, 26 male and female healthy volunteers under euglycemic clamp received two alternate 0.2 U/kg doses of both BioChaperone Lispro U100 and BioChaperone Lispro U200. The primary objective was a comparison of BioChaperone Lispro U200 to BioChaperone Lispro U100 with respect to two 2 standard bioequivalence parameters, Cmax and AUClispro(0-infinity), and two supporting ultra-rapid properties, AUClispro (0-1h) and early t50% Cmax lispro. Based on pre-defined criteria, the results show that BioChaperone Lispro U200 retained the ultra-rapid profile of BioChaperone U100.
These positive feasibility results support the development of BioChaperone Lispro U200 based on demonstration of bioequivalence.
“It’s important for us to research and understand ways to address the differing needs of people with diabetes,” said Thomas Hardy, M.D., Ph.D., senior director, Lilly Research Laboratories. “With these results, we are encouraged that BioChaperone Lispro may help meet these diverse needs by providing an ultra-rapid prandial insulin that could also be available as a concentrated U200 formulation.”
• Adocia receives a $10 million milestone payment from Lilly after successful completion of this clinical pilot study.
Lyon and Indianapolis, December 11, 2015 – Adocia (Euronext Paris: ADOC) and Eli Lilly and Company (NYSE: LLY) announced today the successful completion of a preliminary Phase 1 clinical trial evaluating BioChaperone Lispro U200, a concentrated formulation of BioChaperone Lispro, the ultra-rapid formulation of insulin lispro licensed to Lilly. This completed pilot study aimed to determine the potential for bioequivalence of BioChaperone Lispro U200 to BioChaperone Lispro U100 in healthy volunteers.
There is a current trend toward insulin products with a higher concentration, primarily to meet the need for reduced injection volumes. Recently, Lilly’s Humalog® 200 units per mL (U-200), the first concentrated mealtime insulin analog and a new formulation of insulin lispro, was approved and launched in Europe and in the United States. Humalog U200 was established bioequivalent to Humalog 100 units per mL (U-100) in healthy volunteers. However, an ultrarapid version of concentrated insulin may better mimic the physiological timing of prandial insulin action.
“The excellent results of this pilot study are an important milestone in the advancement of the ultra-rapid BioChaperone Lispro development program,” says Olivier Soula, Adocia’s R&D Director and Deputy General Manager. “The ability of BioChaperone technology to accelerate the absorption of insulin lispro at both U100 and U200 concentrations could play an important role in expanding and strengthening the Humalog franchise.”
In this four-period crossover, randomized, double-blind study, 26 male and female healthy volunteers under euglycemic clamp received two alternate 0.2 U/kg doses of both BioChaperone Lispro U100 and BioChaperone Lispro U200. The primary objective was a comparison of BioChaperone Lispro U200 to BioChaperone Lispro U100 with respect to two 2 standard bioequivalence parameters, Cmax and AUClispro(0-infinity), and two supporting ultra-rapid properties, AUClispro (0-1h) and early t50% Cmax lispro. Based on pre-defined criteria, the results show that BioChaperone Lispro U200 retained the ultra-rapid profile of BioChaperone U100.
These positive feasibility results support the development of BioChaperone Lispro U200 based on demonstration of bioequivalence.
“It’s important for us to research and understand ways to address the differing needs of people with diabetes,” said Thomas Hardy, M.D., Ph.D., senior director, Lilly Research Laboratories. “With these results, we are encouraged that BioChaperone Lispro may help meet these diverse needs by providing an ultra-rapid prandial insulin that could also be available as a concentrated U200 formulation.”
