Clinical Trials

* On April 9, 2014, Adocia has announced positive results from a phase IIa clinical trial evaluating its innovative ultra-fast formulation of insulin Lispro in comparison to Eli Lilly’s Humalog® commercial insulin. Adocia’s formulation incorporates proprietary BioChaperone® technology which enables accelerated absorption of prandial insulins.The study met its primary endpoint, showing a significant increase in BioChaperone®Lispro bioavailability in the first half-hour compared to Humalog®. This parameter is critical as the ultimate goal for prandial insulins is an immediate absorption in the blood following subcutaneous injections. This result demonstrates that BioChaperone® Lispro more closely mimics the endogenous insulin secretion observed in healthy individuals in response to a meal. In this double-blind crossover study, the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of BioChaperone Lispro were compared to those of Humalog®. Thirty-six patients with type I diabetes received single 0.2 U/kg doses of BioChaperone® Lispro and Humalog® under automated euglycemic clamp conditions (ClampArt®, target blood glucose (BG) 100 mg/dL, clamp duration six hours post-dosing).
Both formulations were well tolerated and did not induce any local reaction. BioChaperone® Lispro has a significantly faster rate of absorption than Humalog with an increase in the early insulin exposure of 170 per cent (primary endpoint, AUCLispro_0-30min 23.7 ± 11.4 vs. 9.5 ± 6.2 h*mU/L; p<0.0001). The time to peak insulin concentration was reduced by more than 35 per cent (Tmax 42 ± 11 vs. 69 ± 22 min; p<0.0001). BioChaperone® Lispro was cleared from the blood significantly earlier than Humalog®, reflected in the time to half-maximum insulin levels after Tmax (late T50 per cent max = 141 ± 43 vs. 173 ± 41 min, p<0.0001).
The acceleration of insulin Lispro absorption translated into a significant acceleration of insulin action. The metabolic effect is triggered significantly earlier for BioChaperone® Lispro than for Humalog with 30 per cent faster onset of action (Tonset = 23.1 ± 7.0 vs. 34.4 ± 15.3 min; p<0.0001). The early metabolic effect is increased by 69 per cent relative to Humalog during the first hour after administration (AUCGIR_0-1h = 218 ± 88 vs. 129 ± 63 mg/kg; p<0.0001). The time to reach the maximal observed hypoglycemic effect is significantly shorter relative to Humalog (TGIR_max = 99 ± 42 vs. 133 ± 45 min; p=0.0002).
Finally, the total insulin exposure and potency of insulin Lispro was similar for both formulations.
The clinical data has been submitted for communication to the 74th scientific sessions of the American Diabetes Association (ADA) and the 50th European Association for the Study of Diabetes (EASD) annual meeting.

BioChaperone® Lispro now has a complete clinical data package ready to support the next clinical trial, a dose-response study which will be launched this quarter. This trial will be conducted in Germany by the same CRO, Profil Neuss. According to the current design, the primary goal of the study is to examine the dose-response and dose-exposure of BioChaperone Lispro. The trial is expected to enroll 36 type I diabetic patients under automated euglycemic clamp conditions with three doses of BioChaperone Lispro and one dose of Humalog. Results are expected before the end of 2014. Adocia plans to follow a similar development plan for HinsBet, the prandial fast-acting human insulin formulated using BioChaperone. HinsBet is on track to enter a phase IIa dose-response clinical trial expected to start in the third quarter of 2014. In parallel, Adocia intends to meet both the FDA for a pre-IND meeting in 2014 and the EMA for a scientific advice to validate its clinical development plans for both prandial insulins.

* On January 6, 2014, Adocia has launched a phase IIa clinical trial on its ultra-fast acting formulation of insulin Lispro (Humalog®, Eli Lilly) using its proprietary technology BioChaperone®). This clinical trial aims to demonstrate that the BioChaperone Lispro formulation acts faster than Humalog, which would allow patients to achieve a better glycemic control after a meal. During this study, pharmacodynamic and pharmacokinetic profiles of the BioChaperone Lispro formulation will be compared to those of Humalog in a cross-over design on 36 type I diabetic patients under euglycemic clamp. The first patients of this double-blind study conducted by Profil, a German CRO specialized in diabetes, have already been treated. Results from this study are expected during the second quarter of 2014. During the first phase I clinical study, performed by Eli Lilly on healthy volunteers, the BioChaperone Lispro formulation reached all its predefined clinical endpoints