Advertisement Adocia reports positive Phase IIa trial results of HinsBet in type 1 diabetes patients - Pharmaceutical Business review
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Adocia reports positive Phase IIa trial results of HinsBet in type 1 diabetes patients

French biotechnology firm Adocia has reported positive results from a Phase IIa clinical trial evaluating its new fast-acting formulation of recombinant human insulin, HinsBet, compared to Eli Lilly’s products Humalog (insulin lispro) and Humulin (recombinant human insulin) in patients with type 1 diabetes.

Adocia’s HinsBet formulation incorporates BioChaperone technology which allows accelerated absorption of prandial insulins.

The company said that the trial met its primary endpoint, measuring the increase of recombinant human insulin bioavailability during the first hour for HinsBet as compared to Humulin.

Prandial insulins are designed to mimic physiological response to a meal with an absorption of subcutaneous insulin as fast as possible.

The results show that HinsBet has an early effect equivalent to that of a fast-acting insulin analog, Humalog, and twice superior to that of regular recombinant human insulin, Humulin.

Adocia R&D director and deputy general manager Olivier Soula said: "We are extremely pleased with the performance of this optimized formulation of HinsBet in type 1 diabetic patients as it shows that our product is superior to regular human insulin and has an efficacy identical to Humalog in the first hour.

"This new result demonstrates once more the value of the BioChaperone technology to improve the performance of approved insulins."

The double-blind crossover trial also compared the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HinsBet with those of Humulin and Humalog.

A total of 36 patients with type 1 diabetes received single 0.2 U/kg doses of HinsBet, Humulin and Humalog under automated euglycemic clamp conditions.

The company said that all three formulations were well tolerated and did not induce any local reaction.

HinsBet had a faster rate of absorption compared to Humulin with an increase in the early insulin exposure of 70%.