Adocia and its Chinese partner Tonghua Dongbao announced positive topline results from a Phase 3 clinical trial evaluating BioChaperone Lispro (THDB0206 injection), an ultra-rapid insulin formulation for Type 2 diabetes treatment. The randomized, open-label, multicenter study successfully met its primary endpoint, demonstrating non-inferior HbA1c reduction compared to the standard of care Humalog after 26 weeks of treatment.
Trial Design and Results
The Phase 3 study (NCT05834868), approved by Chinese regulatory authorities, enrolled 1,040 Chinese adults with Type 2 diabetes who had inadequate glycemic control despite using daily multiple insulin injections. After 26 weeks of treatment, both the THDB0206 injection group and the Humalog control group showed significant HbA1c decreases from baseline, with comparable reductions meeting the primary endpoint.
Key secondary endpoints were also achieved, with THDB0206 demonstrating a statistically significant lower rise in blood glucose after a standard meal compared to Humalog. The 10-point self-monitoring blood glucose (SMBG) measurements at week 26 confirmed the advantage of THDB0206 in controlling postprandial blood glucose fluctuations, showing statistically improved daily blood glucose levels.
"THDB0206 injection is a new generation of ultra-rapid insulin that has demonstrated benefits for improving blood glucose control of adults with Type 2 diabetes compared with the standard of care Humalog," said Dr. LENG Chunsheng, President of Tonghua Dongbao.
Safety Profile
The safety and tolerability profile of THDB0206 injection was favorable, with most adverse events classified as mild or moderate. The incidence of adverse events and hypoglycemic episodes was similar to that observed with Humalog, indicating comparable safety between the two treatments.
Technology Platform
BioChaperone Lispro combines Adocia's proprietary BioChaperone technology with insulin lispro, the active ingredient in Humalog. This innovative formulation acts significantly faster than earlier insulin generations, effectively reducing post-meal hyperglycemia, which contributes to long-term complications such as retinopathy, diabetic foot ulcers, and kidney failure.
The rapid elimination profile of BioChaperone Lispro minimizes hypoglycemia risk, often caused when insulin levels remain elevated after post-meal glucose levels have normalized. The faster action profile enhances compatibility with modern diabetes management systems, particularly insulin pump systems, and provides better integration into advanced treatment algorithms.
Clinical Impact and Partnership
Olivier Soula, CEO and Co-Founder of Adocia, emphasized the significance of the results: "Given the well-known challenges in showing clinical improvement in this population with a new prandial insulin, we are particularly delighted with these findings. This milestone demonstrates Adocia's ability to advance its innovative treatments to the final stages of clinical development, within strategic partnerships."
BioChaperone Lispro was licensed to Tonghua Dongbao in 2018 as part of a licensing agreement covering China and other Asian countries. Tonghua Dongbao Pharmaceutical Co. Ltd, listed on the Shanghai Stock Exchange since 1994, specializes in insulin R&D, manufacturing, and commercialization, with over 3,000 employees and approximately $280 million in sales.
Quality of Life Benefits
Beyond clinical advantages, the quick onset of BioChaperone Lispro improves patient quality of life by offering greater flexibility in dose timing. Patients can administer insulin at mealtime or even immediately after eating, allowing for more accurate dosing based on known meal timing and content. This flexibility reduces risks of over- or underdosing, which can lead to hypo- or hyperglycemia and associated complications.
The simplified dosing process eases the psychological burden on patients and caregivers, significantly alleviating stress associated with diabetes management. The enhanced dosing flexibility represents a meaningful advancement in diabetes care, particularly for patients requiring multiple daily insulin injections.
