Adocia initiates a clinical study on the post-meal effect of ultra-rapid BioChaperone Lispro insulin formulation
Adocia has announced the initiation of a Phase Ib clinical trial evaluation for BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Eli Lilly and Company. This formulation uses Adocia’s proprietary technology BioChaperone, which is believed to enable the acceleration of insulin absorption.
This is the first study to be initiated as part of the Adocia-Lilly partnership. The study aims to measure the effect of BioChaperone Lispro, injected at the time of a standardized meal, on post-meal glycemic control in type 1 diabetes patients and compare this effect to that of Humalog (insulin lispro rDNA origin). Commercialized fast-acting insulin analogs are usually injected before the meal. An ultra-rapid insulin, meanwhile, aims to allow injection at the time of the meal, or even after the start of a meal, with the goal of reducing the magnitude of glycemic excursions. This study will be sponsored by Adocia, and performed by Profil in Germany.
“We are very pleased to announce the first clinical trial in collaboration with Lilly just a month after the signature of the agreement between our companies,” says Olivier Soula, Adocia’s R&D Director and Deputy General Manager. “This trial is the first step in testing the possible medical benefit of our ultra-rapid insulin formulation for diabetes patients.”
In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive one dose of BioChaperone Lispro and one dose of Humalog when taking a standardized meal. The main objective of this study is to compare post-meal glycemic control obtained after the injection of either BioChaperone Lispro or Humalog. The pharmacokinetic profiles of both products will also be monitored.
“At the end of 2014, we received the initial $50 million up-front payment written under the contract,” adds Gérard Soula, Chief Executive Officer of Adocia. “Based on our strong cash position, we will actively pursue the development of our other innovative projects.”
This trial (2014-005028-92) is registered and will appear on clinicaltrials.gov.