Adocia, the clinical biopharmaceutical company focused on developing innovative formulations of approved proteins for the treatment of diabetes, announced positive topline results of a clinical study evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro, compared to Novolog (insulin aspart, Novo Nordisk), a rapid-acting insulin analog, and Fiasp (faster-acting insulin aspart, Novo Nordisk), the only EMA-approved (European Medical Agency) and FDA-approved (Federal Drug Administration, USA) “ultra-rapid acting” insulin formulation.
This phase 1 study in insulin pumps is the first head-to-head comparison of two “ultra-rapid acting” insulin formulations. In this double-blind, randomized, three-period crossover study, 42 participants with type 1 diabetes received single doses (0.15 U/kg), under a euglycemic clamp procedure, of BioChaperone Lispro U100, Fiasp and Novolog, administered by an insulin pump (Medtronic MiniMed Paradigm Veo) on three separate dosing visits. Objectives of the study included the comparison of the glucodynamic effects and the pharmacokinetic profiles obtained with the three agents. Safety and tolerability assessments were also performed.
“The compelling performance of BioChaperone Lispro in a pump setting establishes our product as a strong contender in the emerging ultra-rapid insulin class, across a full array of injection devices.” commented Olivier Soula, Deputy General Manager and R&D Director of Adocia. “With major diabetes players actively pursuing an integrated model to exploit synergies between therapeutics, smart devices and connected care, we are convinced that ultra-rapid insulin will be a critical component in delivering better outcomes for people with diabetes.”
BioChaperone Lispro met the primary objective of the study by demonstrating a statistically significant 63% increase in metabolic effect during the first hour vs. Novolog (LS- Mean AUCGIR 0_1h = 162 mg/kg vs. 99 mg/kg; p<0.0001), confirming the ultra-rapid profile observed in previous studies vs. Humalog (insulin lispro, Eli Lilly).
Additionally, BioChaperone Lispro displayed a statistically significant faster-off metabolic profile vs. both other products, reaching late half-Tmax 18 minutes before Fiasp and 22 minutes before Novolog (Late Time to 50% of GIRmax = 210 min for BioChaperone Lispro vs. 228 min for Fiasp; p=0.0017 and 232 min for Novolog, p=0.002). BioChaperone Lispro also demonstrated a similar early metabolic effect as Fiasp during the first hour (LS- Mean AUCGIR 0_1h = 162 mg/kg vs. 154 mg/kg; NS). All three treatments lead to similar total effects.
“This study confirmed not only BioChaperone Lispro’s ultra-rapid action profile, but also its best-in-class pharmacodynamic performance in an insulin pump, a setting in which the most impressive results of Fiasp to date have been reported. Interestingly, in all our BioChaperone Lispro studies, our product has shown extremely consistent performance across devices and patient populations.” commented Dr. Stanislav Glezer, Adocia’s chief medical officer. “These data support the potential of BioChaperone Lispro to become the most precise insulin tool for achieving glycemic control, which is a daily struggle for many people living with diabetes.”
Dr. Bruce Bode, M.D, FACE, Clinical Associate Professor at Emory University (USA), added “Insulin pumps are currently used by approximately 40% of people with type 1 diabetes in the United States. For these people, the emergence of hybrid closed-loop delivery systems is a great stride towards better glycemic control and improved quality of life. In addition to the rapid onset of action, the faster-off effect observed with BioChaperone Lispro in this study could be critical to potentiate the effect of the algorithms used in these systems. As such, it brings tremendous hope for better diabetes management solutions in the near future.”