Strong early results for Eli Lilly's fast-acting insulin formulation

Illustration of BioChaperone formulation of insulin--Courtesy of Adocia

Eli Lilly ($LLY) reported strong Phase I results of its BioChaperone Lispro ultrarapid formulation of insulin, which it in-licensed from Lyon, France's Adocia for $50 million upfront and up to $520 million in milestone payments. The candidate is designed to enable injections before, during or after meals due to its fast-acting nature.

The study compared Lispro to Lilly's Humalog on postprandial glycemic control relative to solid standardized meals in 36 Type 1 diabetes patients, according to a release.

In the 14-day study, patients were injected with either Lispro or Humalog at the time of, 15 minutes before, or 15 minutes after a test meal. The trial had a crossover design, meaning all patients received both medications for two consecutive weeks, or a total of 28 days. That way each patient is his or her own control.

At the beginning of the study, Lispro achieved a statistically significant 31% reduction in blood glucose over the first two hours compared to Humalog, and a statistically significant 42% reduction on day 14, according to a release. The meal tolerance test was carried out on days 1-3 of the study, as well as day 14, according to ClinicalTrials.Gov.

"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 Adocia chief medical officer Dr. Simon Bruce in a statement. "We also saw excellent preliminary safety results in the outpatient setting, with no observed difference between the treatments."

FDA approval would result in milestone payments to Adocia worth $280 million, and the chance to earn sales milestone payments of up to $240 million, as well as royalties, according to a 2014 release.

Adocia's BioChaperone platform improves the performance of proteins by merging with them to form a physical complex, according to the company website. It's also being deployed to develop a combination of prandial and basal insulin based on insulin glargine and a fast-acting human insulin, as well as a candidate for diabetic foot ulcers.

- read the release