Diamyd Medical has announced a strategic partnership with INNODIA, an international non-profit organization focused on advancing research for disease-modifying therapies in Type 1 Diabetes (T1D). The collaboration aims to enhance patient enrollment and visibility for the DIAGNODE-3 trial, a Phase 3 precision medicine study, potentially paving the way for an accelerated Biologics Licensing Application (BLA) in the U.S.
Leveraging INNODIA's Network
The partnership will utilize INNODIA’s extensive clinical network within Europe to broaden the reach of the DIAGNODE-3 trial. Ulf Hannelius, CEO of Diamyd Medical, stated, “We are delighted to work with INNODIA to spread the awareness of Type 1 Diabetes and Diamyd®, as well as to ensure that we meet critical recruitment milestones in DIAGNODE-3 ahead of a potential BLA under the Accelerated Approval Program.” Manuela Battaglia, Managing Director of INNODIA, added that the collaboration advances their shared mission of improving lives for individuals with Type 1 Diabetes.
DIAGNODE-3 Trial Details
The DIAGNODE-3 trial (www.diagnode-3.com) is a confirmatory Phase 3 study assessing the safety and efficacy of Diamyd®, an antigen-specific immunotherapy, in individuals recently diagnosed with Type 1 Diabetes. The trial is being conducted in the United States and across eight European countries, including Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary, and Estonia. The trial aims to enroll up to 330 individuals aged 12 to 29 years, diagnosed within six months of enrollment, who carry the HLA DR3-DQ2 haplotype, a genetic risk factor for Type 1 Diabetes. Further stratification based on HLA haplotypes will assess potential super-responder groups, specifically those positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.
The trial design is based on efficacy and safety data from the Phase 2a and Phase 2b DIAGNODE-1 and DIAGNODE-2 trials, as well as a meta-analysis of data from over 600 individuals from previous Phase 2 and Phase 3 trials involving Diamyd®. The co-primary endpoints include preservation of endogenous insulin-producing capacity, measured as stimulated C-peptide, and improved blood glucose control, as determined by HbA1c levels.
About Diamyd Medical and INNODIA
Diamyd Medical focuses on developing precision medicine therapies for preventing and treating Type 1 Diabetes and Latent Autoimmune Diabetes in Adults (LADA). Diamyd® has received Orphan Drug Designation in the U.S. and Fast Track Designation from the FDA for treating Stage 1, 2, and 3 Type 1 Diabetes. INNODIA is dedicated to accelerating the development of preventive and curative therapies for Type 1 Diabetes, empowering medicine developers with the tools and services needed to halt the progression of the disease.
