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news.Adocia announced that BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), the German regulatory agency for drugs and medical devices, has approved the initiation of a Phase IIa clinical study of HinsBet, a fast-acting formulation of human insulin.
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HinsBet is a new type of prandial insulin, developed using the Company’s proprietary BioChaperone technology, that has been designed to reconcile the performance of insulin analogs with the cost-effectiveness of human insulin.
The aim of this Phase IIa clinical trial is to demonstrate that HinsBet acts faster than Humulin (human insulin, Eli Lilly) and as fast as Humalog (insulin lispro, Eli Lilly), allowing patients who use human insulin to achieve a better glycemic control after a meal. In this double-blind, randomized, 3 arm, crossover study, the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HinsBet will be compared to those of Humulin and Humalog.
36 patients with type 1 diabetes will receive single 0.2 U/kg doses of HinsBet, Humulin and Humalog under automated euglycemic clamp conditions. Adocia plans to dose the first patient during the first week of August. Results are expected in Q1 2015. Many insulin-dependent diabetic patients rely on prandial insulin to control their glycemia after a meal.
These treatments aim to replicate the quasi-immediate secretion of insulin observed in healthy people when having a meal.
Two main prandial insulin options are available, human insulin and fast-acting insulin analogs. About 80% of diabetic patients, i.e. more than 300 million, live in low- and middle-income countries (1). In those countries, human insulin remains the prandial insulin treatment of choice due to its greater affordability and accessibility.
However, human insulin acts more slowly than insulin analogs, requiring patients to inject 30 minutes before the meal instead of 15 minutes with insulin analogs. This additional delay represents a real obstacle for patients to control their glycaemia and puts them at risk of hyper- and hypo-glycaemia.
"Diabetic patients have the same medical needs, wherever they may live," commented Gérard Soula, CEO of Adocia "With HinsBet, our objective is to make improved insulin treatment accessible to the largest 1 population of patients, by offering a product that combines the efficacy of insulin analogs with the lower price of human insulin".
The accelerated action of human insulin observed with HinsBet has been enabled by the proprietary BioChaperone technology, as demonstrated in two previous clinical studies. In addition, this technology has already proven to be safe and to also accelerate the action of another insulin, insulin lispro, in a phase IIa clinical study on type 1 diabetic patients.
"We are excited to launch this new study with HinsBet after the successful phase IIa study with BioChaperone Lispro U100" stated Olivier Soula, General Deputy Manager and Director of R&D at Adocia.
"The BioChaperone technology accelerates the action of all prandial insulins, as reflected by our prandial insulin portfolio: HinsBet, BioChaperone Lispro, currently being tested in a Phase II, dose-response study and BioChaperone Lispro U300 for which we are preparing a clinical study."