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.
Adocia is therefore entering the second stage of the clinical development plan of its ultra-fast acting analog insulin. During the first phase I clinical study, performed by Eli Lilly on healthy volunteers, the BioChaperone Lispro formulation reached all its predefined clinical endpoints.
“The objective of our ultra-fast analog insulin is to enhance post-prandial glycemic control in order to avoid hyperglycemia, which is responsible for long term side-effects of diabetes like retinopathy or cardiovascular issues,” said Olivier Soula, VP R&D director at Adocia. “After this second stage, we intend to follow an accelerated clinical development pathway comparable to the one taken by Novo Nordisk with its reformulation of insulin Aspart.”
“During preclinical studies, we demonstrated that BioChaperone has the same accelerating effect on all three fast-acting analog insulins on the market, namely Humalog, NovoLog® (Novo Nordisk) and Apidra® (Sanofi). This clinical trial on Humalog should establish the human proof of concept for all these insulins, which represent a USD 5 billion market,” said Gerard Soula, CEO of Adocia.