Adocia (ADOC), a clinical-stage biopharmaceutical company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and other metabolic diseases, announces that its partner Tonghua Dongbao releases today 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.
“Our sales in insulin analogues have been recording an impressive growth in recent years, and we are extremely pleased about the prospect of soon adding BioChaperone® Combo to our portfolio of innovative insulins,” says Dr Chunsheng Leng, Chairman and CEO of Tonghua Dongbao. “These three successful studies bring the product one step closer to being available to Chinese people suffering from diabetes“.
“I would like to express our gratitude to Tonghua Dongbao for entrusting us with the conduct of these studies,” says Olivier Soula, Chief Executive Officer of Adocia. “I am particularly pleased with the results of these clinical studies, which underline the potential of BC Combo to bring additional medical value to people with diabetes, seeking once- or twice-daily insulin injections, ensuring the basal and prandial glycemic control. Tonghua Dongbao can count on our full support to continue the successful development of BC Combo.”
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.