Adocia and Lilly report positive early results for ultra-rapid insulin
pharmafile | March 15, 2016 | News story | Manufacturing and Production, Research and Development | Adocia, BioChaperone Lispro, Eli Lilly, insulinm
Eli Lilly and development partner Adocia have announced today positive topline results from a Phase 1b clinical trial of ultra-rapid insulin, BioChaperone Lispro.
The Phase 1b study of 36 type 1 diabetes patients was the first outpatient 14-day study comparing the effect of multiple daily injections of BioChaperone Lispro and Lilly’s Humalog (insulin lispro rDNA origin) on post-prandial glycemic control, relative to solid standardised meals.
The insulin lispro, licensed to Lilly, was developed using France-based Adocia’s proprietary technology BioChaperone, which is designed to accelerate insulin absorption. The companies teamed up in December 2014, with Lilly paying Adocia $50 million upfront for the promising treatment. If BioChaperone ultimately wins approval, the total payed could rise well beyond $500 million.
The study also tested different timings of administration, with treatments being injected either at mealtime, 15 minutes before, or 15 minutes after the start of a solid meal. Whereas commercialised fast-acting insulin analogs are usually injected before meals, ultra-rapid insulins like BioChaperone aim to allow injection at the time of the meal, or even after the start of a meal, while still maintaining a reduction in the magnitude of glycaemic excursions.
“We are extremely pleased to confirm that BioChaperone Lispro consistently delivered superior post-prandial control compared to Humalog, especially after a real-life solid meal. BioChaperone Lispro proved to offer a robust performance throughout the study period,” says Simon Bruce, Adocia’s chief medical officer. “We also saw excellent preliminary safety results in the outpatient setting, with no observed difference between the treatments.”
At the beginning of the study, when injected at the time of meal, BioChaperone Lispro demonstrated a statistically significant 31% reduction in blood glucose excursion over the first two hours compared to Humalog. After 14 days of treatment for each treatment, BioChaperone Lispro also demonstrated a statistically significant 42% reduction in blood glucose excursion over the first two hours compared to Humalog, when injected at the time of the meal. Both drugs were similarly well tolerated in the study, with no new unexpected safety findings observed.
“This was an important study and provides our first experience with repeat doses of this ultra-rapid insulin formulation in an outpatient setting,” says Thomas Hardy, senior medical director, Lilly Research Laboratories. “We are encouraged by these results and look forward to seeing the results of additional, ongoing studies.”
Joel Levy
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