LYON, France & INDIANAPOLIS—A potential new insulin option is gaining clinical momentum with the announcement that Adocia and Eli Lilly and Co. have begun a Phase 1b clinical trial to evaluate BioChaperone Lispro. Participants in this study—which will consist of 36 type 1 diabetes patients—will receive multiple daily doses of BioChaperone Lispro and Humalog (insulin lispro rDNA origin) over two periods of 14 days each, either at mealtime or 15 minutes after the meal. Adocia will sponsor the study, which will be performed by Profil Neuss in Germany. While the main objective is to compare post-meal glucose profiles after identical bolus injections of either BioChaperone Lispro or Humalog relative to a solid meal stimulus, the study will also evaluate the safety and efficacy of an ultra-rapid insulin absorption profile in an outpatient setting.
“This new clinical study aims to further document the potential benefit of BioChaperone Lispro,” said Olivier Soula, R&D director and deputy general manager of Adocia. “We continue to move rapidly to characterize the clinical effects of the ultra-rapid insulin lispro profile and prepare the product for Phase 3 clinical testing.”
BioChaperone Lispro is an ultra-rapid formulation of insulin lispro licensed to Lilly and formulated using Adocia’s proprietary technology BioChaperone, which is designed to accelerate insulin absorption. There are some weaknesses to the existing insulin therapies, says Gérard Soula, CEO of Adocia, primarily the fact that they need to be injected 15 to 20 minutes before a meal, as “there is a delay after injection before insulin can reach the blood circulation.” This can be especially difficult to deal with in the case of children who are diabetic, he notes.
“The purpose of this formulation is to have a shorter delay, in order that the patient can administer the insulin at the mealtime or even after the meal,” Soula tell DDNews. He notes that Lilly stood out as an ideal partner for this work due to its experience in the diabetes market—and of course, with Humalog—as well as its knowledge of the process for introducing a new insulin formulation.
Lilly and Adocia inked a worldwide licensing collaboration to develop BioChaperone Lispro for individuals with type 1 and type 2 diabetes in December 2014. Per the terms of the agreement, Lilly is responsible for future development, manufacturing and commercialization of BioChaperone Lispro. Adocia will receive $50 million in an upfront fee, with the potential for future payments of up to $280 million if certain development and regulatory milestones are met and up to $240 million in sales milestones payments, as well as tiered sales royalties. Lilly will reimburse Adocia for certain research and development expenses, and a concentrated formulation of BioChaperone Lispro is also included in this agreement.
“An ultra-rapid acting insulin, if approved by regulators, could provide a new important treatment option for people with type 1 and type 2 diabetes,” Enrique Conterno, president of Lilly Diabetes, said in a press release announcing the alliance. “An ultra-rapid acting insulin would be a natural fit in our growing portfolio.”
The first study in this partnership was a Phase 1b trial, which was initiated in January of this year with the goal of looking at the effect of Humalog and BioChaperone Lispro, injected at the time of a meal, on post-meal glycemic control in type 1 diabetics. Adocia and Lilly announced the study’s completion in July as well as the positive results from the trial. BioChaperone Lispro produced a 61-percent reduction in post-prandial glucose excursion over the first two hours compared to Humalog. This matched previous clinical findings from another trial that found that BioChaperone Lispro has a significantly faster rate of insulin lispro absorption than Humalog, with an increase in the early insulin exposure of 168 percent. Both drugs led to similar numbers of hypoglycemia episodes, and no local reactions were seen at the administration sites for either one.