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 seeks to leverage INNODIA's extensive clinical network within the EU to enhance patient enrollment and increase visibility for the Phase 3 trial DIAGNODE-3. This trial is crucial for a potential accelerated Biologics Licensing Application (BLA) in the U.S.
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 actively recruiting participants 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 clinical efficacy and safety data from the Phase 2a and Phase 2b trials DIAGNODE-1 and DIAGNODE-2, 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 the preservation of endogenous insulin-producing capacity, measured as stimulated C-peptide, and improved blood glucose control, determined by HbA1c.
Strategic Rationale
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. This partnership enhances our ability to bring Diamyd® to market, potentially as a first-in-class precision treatment for Stage 3 Type 1 Diabetes."
Manuela Battaglia, Managing Director of INNODIA, added, "By joining forces with Diamyd Medical, we are advancing our shared mission of improving lives for persons with Type 1 Diabetes. INNODIA's network will be instrumental in reaching patients across Europe, contributing to this transformative effort."
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. In addition to DIAGNODE-3, Diamyd Medical is developing Remygen®, a GABA-based investigational drug, for metabolic diseases. The company is also a major shareholder in NextCell Pharma AB and MainlyAI AB.
