Adocia reports positive preliminary results for first clinical trial of BioChaperone Combo

Feb 27 2014

Adocia (Euronext Paris : FR0011184241 - ADOC) announces today positive preliminary results for the first clinical trial on an innovative formulation combining insulin analog Glargine (Lantus(R), Sanofi), the gold standard basal insulin, with a rapid-acting insulin analog, Lispro (Humalog(R), Eli Lilly) using Adocia's BioChaperone(R) technology.

BioChaperone technology enables the solubilization of insulin Glargine at physiological pH, which enables its combination with prandial insulins analogs such as insulin Lispro in solution. Eight patent applications have been filed to protect this innovation until 2032.

The objective of this trial was to show that this combination of the most widely used basal insulin (Lantus) and one of the best commercial prandial insulins (Humalog) formulated with the BioChaperone technology has the potential to help patients improve their blood glucose control more effectively than with a Premix formulation of insulin analog (Humalog Mix(R), Lispro and Protamine).

“The preliminary clinical efficacy results show how the BioChaperone Combo could offer patients both the long-lasting effect of Glargine, which is the gold-standard in basal insulin and the fast action of a prandial insulin analog. This confirms the product’s strong market potential,” said Olivier Soula, Deputy General Manager of Adocia. “From a regulatory point of view, we should benefit from a simplified clinical development path. Development could be short and less costly as Glargine and Lispro have both been on the market for many years and share a proven track record of clinical safety.”

Trial Design

This clinical trial, conducted by Profil (CRO, Germany) was a double blind, two-way crossover study that enrolled 20 patients with type 1 diabetes under euglycemic clamp conditions. As part of the crossover design, all patients were treated with BioChaperone Combo and Humalog Mix 25 at the same dose of 0.8 IU/kg. The composition of BioChaperone Combo is based on 75/25 basal prandial ratio like in Humalog Mix 25. Pharmacokinetic (PK) and pharmacodynamic (PD) measurements were taken as patients were monitored for 30 hours after administration. The objective of the study was a comparison of pharmacodynamic (PD) and pharmacokinetic (PK) profiles of the combination of BioChaperone with Glargine/Lispro (75/25) to those of Humalog Mix 25. Safety and tolerability were also evaluated in this study.

Efficacy Results Demonstrate Proof of Concept

The study demonstrated that BioChaperone Combo has the ability to deliver insulin with a faster onset and longer duration of action compared to Humalog Mix:

- BioChaperone Combo had a greater than 30 per cent faster onset of action as compared to Humalog Mix.

- Almost all patients treated with BioChaperone Combo experienced a minimal duration of action in excess of 30 hours (end of monitoring).

- Both formulations of insulins (BioChaperone Combo and Humalog Mix) were well tolerated.

The onset of action is the time when glucose level decreases by at least 5 per cent from the starting level and glucose infusion is started. Minimal duration of action is defined by the time when blood glucose concentration exceeds 6.5 mmol/L (118 mg/dL).

The PK profiles confirm these major conclusions based on PD profiles. The minimal duration of action in excess of 30 hours, support the use of the BioChaperone Combo as a once-a-day insulin treatment. This may provide patients with advantages over Premix formulations that usually require injection two or three times a day. BioChaperone Combo could also be used twice-a-day to support treatment intensification.

“Our ambition is to offer diabetic patients a unique combination of insulins to simplify their lives while giving them access to the best care options. This clinical study is a key step towards this objective. BioChaperone Combo could replace Premix formulations, which represent a market exceeding USD 2.4 billion. They could also capture part of the Lantus market, which is greater than USD 7 billion,” said Gérard Soula, CEO of Adocia. “We believe that BioChaperone Combo also represents a great commercial opportunity for potential partners.”

Adocia intends to publish a detailed analysis when the data become available in a few weeks. Adocia also intends to present the complete results at a major medical conference this year.