Diamyd Medical has announced a strategic partnership with INNODIA, a non-profit organization focused on advancing research for disease-modifying therapies in Type 1 Diabetes (T1D). The collaboration aims to enhance patient enrollment and awareness for the ongoing DIAGNODE-3 Phase 3 trial, potentially expediting the Biologics Licensing Application (BLA) process in the U.S.
Strategic Collaboration Details
The partnership will utilize INNODIA’s extensive clinical network across Europe to broaden the reach of the DIAGNODE-3 trial. Ulf Hannelius, CEO of Diamyd Medical, stated that this collaboration will help meet critical recruitment milestones, potentially leading to the market introduction of Diamyd® as a first-in-class precision treatment for Stage 3 Type 1 Diabetes.
Manuela Battaglia, Managing Director of INNODIA, emphasized that the collaboration aligns with their shared mission of improving the lives of individuals with Type 1 Diabetes. INNODIA’s network is expected to play a crucial role in reaching patients across Europe, contributing significantly to the trial's success.
About the DIAGNODE-3 Trial
DIAGNODE-3 is a confirmatory Phase 3 trial designed to evaluate the safety and efficacy of Diamyd®, an antigen-specific immunotherapy, in individuals recently diagnosed with Type 1 Diabetes. The trial is actively recruiting patients in the United States and 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.
The trial design incorporates further stratification for HLA haplotypes to assess a potential super-responder group of individuals positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8. The primary endpoints of DIAGNODE-3 are the preservation of endogenous insulin-producing capacity, measured as stimulated C-peptide, and improved blood glucose control, determined by HbA1c levels. These endpoints are based on clinical efficacy and safety results from previous Phase 2a and Phase 2b trials (DIAGNODE-1 and DIAGNODE-2), as well as a meta-analysis of data from over 600 individuals from earlier Phase 2 and Phase 3 trials involving Diamyd®.
About Diamyd Medical
Diamyd Medical is focused on developing precision medicine therapies for the prevention and treatment of Type 1 Diabetes and Latent Autoimmune Diabetes in Adults (LADA). Diamyd® has been granted Orphan Drug Designation in the U.S. and Fast Track Designation by the U.S. FDA for treating Stage 1, 2, and 3 Type 1 Diabetes. The company is also developing Remygen®, a GABA-based investigational drug, for treating metabolic diseases and is a major shareholder in NextCell Pharma AB and MainlyAI AB.
