Adocia Announces Positive Results from Phase 3 Trial in China

Phase 3 Trial Outcomes

The Phase 3 trial, conducted by Tonghua Dongbao and approved by Chinese authorities, assessed the efficacy and safety of the THDB0206 injection formulation compared to Humalog® insulin. The study included 550 Chinese adults with Type 1 diabetes who had inadequate glycemic control under multiple daily insulin injections. After 26 weeks of treatment, the reduction in HbA1c was equivalent between the THDB0206 and Humalog® groups, thus meeting the primary endpoint of the study. Additionally, a significant reduction in postprandial glucose rise was observed in the THDB0206 group compared to the Humalog® group, achieving a key secondary endpoint. Glucose monitoring through self-monitoring of blood glucose (SMBG) confirmed the statistical improvement in blood glucose one hour after each meal.

Safety and Tolerance

The safety and tolerance of THDB0206 were deemed satisfactory, with the majority of side effects classified as mild or moderate. The incidence of adverse events, including hypoglycemic events, was similar to that observed with Humalog®. The results of this trial reinforce the positive data already obtained in patients with Type 2 diabetes.

Licensing and Market Authorization

Adocia licensed BioChaperone® Lispro to Tonghua Dongbao in 2018, for the Chinese market and other Asian countries. The agreement includes a contingent payment of 20 million dollars upon market authorization in China, as well as double-digit royalties on sales. Tonghua Dongbao is responsible for applying for market authorization. Adocia retains the rights to develop and license BioChaperone® Lispro in global markets outside of this scope. BioChaperone® Lispro combines Adocia's proprietary technology with lispro insulin, aiming to improve postprandial glycemic control while reducing the risk of hypoglycemia.