Adocia announced that its partner Tonghua Dongbao releases positive results on the three clinical studies conducted on BioChaperone Combo THDB0207 (?BC Combo?) formulation containing insulin glargine and insulin lispro from Tonghua Dongbao. Conducted by Adocia in Germany, these studies were fully funded by Tonghua Dongbao, the Chinese insulin leader to whom BC Combo was licensed in 2018. These studies were approved by the German Health Authority (BfArM1), as well as by the Chinese Regulatory Authorities (CDE2), as part of a Chinese IND3.

As per these interactions, the data generated on the three studies will be submitted to the CDE and used to support the application to enter the next clinical development phase. Results: The following trials were conducted and all three were positives: A Trial Investigating the Dose Linearity and Safety of BioChaperone Combo THDB0207 in Subjects with Type 2 Diabetes (NCT05373212). A Trial Investigating the Pharmacodynamics of BioChaperone Combo THDB0207 Compared with Humalog Mix25 and Simultaneous Injections of Humalog and Lantus in Healthy Chinese Volunteers (NCT05373186).

A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BioChaperone Combo THDB0207 and Lantus and Humalog in Subjects with Type 1 Diabetes (NCT05373199) These three trials demonstrated that BC Combo is effective, with typical characteristics of a combination of long-acting and rapid-acting insulins, and can thus ensure glycemic control during postprandial and fasting phases. Trials were conducted in comparison to Humalog Mix, Humalog and Lantus, in people with type 1 diabetes, type 2 diabetes or on healthy volunteers with Chinese origin. Compared with Humalog Mix, BC Combo has a faster effect, that could be translated in reduced post-prandial hyperglycemia.

BC Combo has a potential for enhanced fasting glucose control, with an improved 24-hour basal control. It also demonstrated a reduced over-exposure that could limit hypoglycemia. Those data support the goal of effective once or twice daily dosing.

BC Combo was safe and well tolerated; no new or unexpected safety findings were reported during the trials. The overall assessment showed that BC Combo had a good benefit/risk ratio, supporting its clinical development into the next phase. BioChaperone Combo THDB0207 (BC Combo) is a fixed combination of two gold standard insulins: long-acting insulin glargine (as contained in the commercial product Lantus) and rapid-acting insulin lispro (as contained in Humalog).

Many patients worldwide prefer to use fixed combinations of long and rapid acting insulins rather than two separate products (simplicity, reduced number of daily injections). BioChaperone Combo targets the premixed insulin market, which accounts for 65% of insulin volumes in China, a country with 140 million diabetic patients. The different clinical studies conducted confirm the potential of BC Combo to reduce postprandial hyperglycemia and the risk of hypoglycemia, while providing 24-hour basal control.