Adocia and Eli Lilly have announced positive topline results from a phase Ib clinical trial under the Adocia-Lilly partnership evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia's proprietary technology BioChaperone, designed to accelerate insulin absorption.
This study was the first outpatient 14-day study comparing the effect of multiple daily injections of BioChaperone Lispro and Humalog (insulin lispro rDNA origin) on post-prandial glycemic control relative to solid standardized meals in 36 patients with type 1 diabetes. The study also investigated the effects of different timing of administration, with treatments being injected either at mealtime, 15 minutes before, or 15 minutes after the start of a solid meal. Whereas commercialized fast-acting insulin analogs are usually injected before the meal, an ultra-rapid insulin aims to allow injection at the time of the meal, or even after the start of a meal, while maintaining a reduction in the magnitude of glycemic 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," said Simon Bruce, M.D., Ph.D., Adocia's chief medical officer. "We also saw excellent preliminary safety results in the outpatient setting, with no observed difference between the treatments."
In the double-blind, randomized, crossover study, 36 patients with type 1 diabetes used individualized doses of either BioChaperone Lispro or Humalog as the short acting insulin in their multiple daily injection regimen, over two periods of 14 days. At the beginning and the end of each period, patients were subject to a meal tolerance test in the clinic to compare post-prandial blood glucose profiles after identical bolus injections immediately before the meal of either BioChaperone Lispro or Humalog relative to a solid standard meal. 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. This last result demonstrates the robustness of the performance of BioChaperone Lispro on a two week period.
"This was an important study and provides our first experience with repeat doses of this ultra-rapid insulin formulation in an outpatient setting," said Thomas Hardy, M.D. Ph.D., senior medical director, Lilly Research Laboratories. "We are encouraged by these results and look forward to seeing the results of additional, ongoing studies."
Both BioChaperone Lispro and Humalog were similarly well-tolerated throughout the 14 days. No new or unexpected safety findings were observed and no local reactions were seen on the site of administration for either treatment.