Adocia and Tonghua Dongbao have announced positive topline results from a phase 3 clinical trial of BioChaperone Lispro (THDB0206 injection), an ultra-rapid insulin formulation, in adults with type 1 diabetes.
The trial, conducted in China and approved by the Chinese Regulatory Authorities, compared THDB0206 injection with standard of care Humalog. A total of 550 adults with inadequate glycaemic control were enrolled, all using multiple daily insulin injections.
After 26 weeks, the study met its primary endpoint, showing non-inferior HbA1c reduction compared to Humalog.
The key secondary endpoint was also achieved, with a statistically significant lower rise in blood glucose after a standard meal for the THDB0206 group. Additional data revealed improved blood glucose levels two hours post-meal and a consistent reduction one hour after each meal, based on 10-point self-monitoring blood glucose (SMBG).
Mr Li, President of Tonghua Dongbao, said: “We are delighted with the positive results from this phase 3 clinical trial, which confirm the benefits of THDB0206 injection for improving blood glucose control of adults with type 1 diabetes. Tonghua Dongbao is committed to continue to innovate in the treatment of diabetes and obesity.”
Olivier Soula, CEO and Co-Founder of Adocia, explained: “We are extremely proud of the phase 3 results achieved in both type 1 and type 2 diabetes: for both populations, we succeeded in improving postprandial blood glucose control after each meal compared to the standard of care. BioChaperone Lispro is the only one of the three ultra-fast insulins to achieve this level of performance across all meals of the day.”
The safety profile of THDB0206 injection was favourable, with most adverse events reported as mild or moderate and comparable to those of Humalog.
