ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone Lispro (THDB0206 injection) in people with T1D

Regulatory News:

Adocia (Euronext Paris: FR0011184241 – ADOC, the “Company”), a clinical-stage biopharmaceutical company focused on the research and development of innovative therapeutic solutions for the treatment of diabetes and obesity, announces that its partner Tonghua Dongbao releases today positive topline results on the second Phase 3 clinical trial on BioChaperone Lispro (THDB0206 injection), a novel Ultra-Rapid Insulin formulation.

Conducted by Tonghua Dongbao, this Phase 3 study was approved by the Chinese Regulatory Authorities (CDE¹). The randomized, open, multicenter study evaluated the safety and efficacy of THDB0206 injection compared to Humalog in adults with Type 1 Diabetes.

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.”

“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,” declared Olivier Soula, CEO and Co-Founder of Adocia. “This achievement positions Adocia among the few innovators in the field of insulin. The challenges related to the development of metabolic peptides such as insulin, GLP-1, amylin, GIP, and glucagon are comparable. Adocia intends to capitalize on its team’s expertise and its rich portfolio of peptide delivery technologies to become a leader in the development of next-generation treatments for diabetes and obesity.”

Results
A total of 550 Chinese adults with Type 1 diabetes with inadequate glycemic control and using daily multiple injections of insulin were randomized.

After 26 weeks of treatment, HbA1c decreased significantly in both groups compared to the baseline. The reduction in the THDB0206 injection group was comparable to that of the Humalog group, meeting the primary endpoint.

The first key secondary endpoint was also demonstrated, with a statistically significant lower rise of blood glucose after a standard meal for the THDB0206 injection group, compared to the Humalog group. In addition, the study shows a significant trend of blood glucose improvement 2 hours after a standard meal for the THDB0206 injection group, compared to the Humalog group.