- This Phase 3 clinical trial on BioChaperone Lispro (THDB0206 injection) conducted in China in people with Type 2 diabetes, successfully demonstrated, in comparison with standard of care Humalog:
- Non inferior HbA1c reduction at 26 weeks (primary endpoint)
- Significant reduction of the rise of blood glucose after a test meal (key secondary endpoints)
- Mean blood glucose level over the day monitored by 10-point SMBG, an important supportive endpoint, was also significantly decreased, in comparison with Humalog
- A series of prespecified subgroup analyses in HbA1c fully support the benefit of the product in long term blood glucose control
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 Phase 3 clinical trial on BioChaperone Lispro (THDB0206 injection), a novel Ultra-Rapid Insulin formulation.
Conducted by Tonghua Dongbao, this Phase 3 study (NCT05834868) was approved by the Chinese Regulatory Authorities (CDE1). The randomized, open, multicenter study evaluated the safety and efficacy of THDB0206 injection compared to Humalogin adults with Type 2 diabetes.
Dr LENG Chunsheng, President of Tonghua Dongbao, said: "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 Tonghua Dongbao is committed to continue to innovate in the treatment of diabetes and obesity."
Olivier Soula, CEO and Co-Founder of Adocia, added: "We are thrilled to share the positive results obtained with BioChaperone Lispro on this Phase 3 clinical trial on people with Type 2 diabetes. 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. We congratulate Tonghua Dongbao's team for the quality of execution of a large Phase 3 trial of over 1,000 people."
Results
A total of 1,040 Chinese adults with Type 2 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 key secondary endpoints were 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.
The 10-point self-monitoring blood glucose (SMBG) of patients at week 26, an important supportive endpoint of the trial, confirmed the advantage of this product in controlling postprandial blood glucose fluctuations, with a statistically improved daily blood glucose level. A series of prespecified subgroup analyzes of the primary HbA1c endpoint also fully confirmed the benefits of this product in long-term blood glucose control in patients with Type 2 diabetes.
In addition, the safety and tolerability of THDB0206 injection were good. Most of the adverse events were mild or moderate, and the incidence of adverse events and hypoglycemic events were similar to those of Humalog
About BioChaperone Lispro
BioChaperone Lispro was licensed to Tonghua Dongbaoin 2018, as part of a Licensing Agreement covering China and other Asian countries2
BioChaperone Lispro is an Ultra-Rapid Insulin, belonging to the latest generation of prandial insulins. It combines Adocia's proprietary BioChaperone technology with insulin lispro, the active ingredient in the standard of care, Humalog(Eli Lilly).
This innovative formulation acts significantly faster than earlier insulin generations, effectively reducing post-meal hyperglycemia, which is a key contributor to long-term complications such as retinopathy, diabetic foot ulcers, or kidney failure. Additionally, its rapid elimination minimizes the risk of hypoglycemia, often caused when insulin level remains high after post-meal glucose levels have normalized.
The faster action profile of BioChaperone Lispro associated to an excellent local tolerance enhances its compatibility with modern diabetes management systems, particularly insulin pump systems, and provides better integration into advanced treatment algorithms.
Beyond its clinical advantages, the quick onset of BioChaperone Lispro improves quality of life by offering greater flexibility in dose timing. Patients can administer insulin at mealtime, or even right-after-mealtime, allowing for more accurate dosing based on known meal timing and content. This reduces the risks of overdosing or underdosing, which can lead to hypo- or hyperglycemia and their associated complications. The simplified dosing process eases the psychological burden on patients and caregivers, significantly alleviating the stress associated with diabetes management.
About Tonghua Dongbao
Tonghua Dongbao Pharmaceutical Co. Ltd (SHSE: 600867), is a pharmaceutical company based in Jilin province, China, specializing in the R&D, manufacturing and commercialization of insulins and other diabetes treatments. Tonghua Dongbao currently employs over 3,000 people and has sales of around $280 million. It has been listed on the Shanghai Stock Exchange since 1994, with a market capitalization of about $2.3 billion.
About Adocia
Adocia is a biotechnology company specializing in the discovery and development of therapeutic solutions in the field of metabolic diseases, primarily diabetes and obesity.
The Company has a broad portfolio of drug candidates based on four proprietary technology platforms: 1) The BioChaperone technology for the development of new generation insulins and products combining different hormones; 2) AdOral, an oral peptide delivery technology; 3) AdoShell, an immunoprotective biomaterial for cell transplantation, with an initial application in pancreatic cells transplantation; and 4) AdoGel, a long-acting drug delivery platform.
Adocia holds more than 25 patent families. Based in Lyon, the company has about 80 employees. Adocia is listed on the regulated market of Euronext Paris (Euronext: ADOC; ISIN: FR0011184241).
Disclaimer
This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers as being reasonable. However, there can be no guarantee that the estimates contained in such forward-looking statements will be achieved, as such estimates are subject to numerous risks including those set forth in the "Risk Factors" section of the universal registration document that was filed with the French Autorité des marchés financiers on April 29, 2025, available at www.adocia.com Those risks include uncertainties inherent in Adocia's short- or medium-term working capital requirements, in research and development, future clinical data, analyses and the evolution of economic conditions, the financial markets and the markets in which Adocia operates, which could impact the Company's short-term financing requirements and its ability to raise additional funds.
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| 1CDE: Center for Drug Evaluation of the National Medical Products Administration |
| 2 Press Release, Apr. 26, 2018: Adocia and Tonghua Dongbao Announce a Strategic Alliance for BioChaperone Combo and BioChaperone Lispro in China |
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Contacts:
Adocia
Olivier Soula
CEO
contactinvestisseurs@adocia.com
+33 (0)4 72 610 610
www.adocia.com
Ulysse Communication
Adocia Press Investor Relations
Bruno Arabian
Nicolas Entz
adocia@ulysse-communication.com
+ 33 (0)6 87 88 47 26
