Diamyd Medical and INNODIA collaborate on Type 1 Diabetes awareness and DIAGNODE-3 trial recruitment

Diamyd Medical has announced a strategic partnership with INNODIA, an international non-profit organization dedicated to advancing research on therapies that modify the course of Type 1 Diabetes (T1D). This collaboration aims to utilize INNODIA's extensive clinical network in Europe to enhance patient enrollment and increase the visibility of the precision medicine Phase 3 trial, known as DIAGNODE-3, with the goal of accelerating a Biologics Licensing Application (BLA) in the United States.

Ulf Hannelius, CEO of Diamyd Medical, expressed enthusiasm about the partnership with INNODIA. He highlighted that this collaboration will significantly aid in raising awareness about Type 1 Diabetes and Diamyd®, ensuring that critical recruitment milestones for the DIAGNODE-3 trial are met ahead of a potential BLA under the Accelerated Approval Program. Hannelius emphasized that this partnership strengthens their capacity to potentially introduce Diamyd® as a pioneering precision treatment for Stage 3 Type 1 Diabetes.

Manuela Battaglia, Managing Director of INNODIA, echoed these sentiments, stating that the joint efforts with Diamyd Medical align with their mission to improve the lives of individuals living with Type 1 Diabetes. She pointed out that INNODIA’s network will be crucial in reaching patients across Europe, thereby contributing significantly to this transformative initiative.

DIAGNODE-3 is a confirmatory Phase 3 trial currently underway in the United States and eight European countries, namely Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary, and Estonia. The trial is set to enroll up to 330 participants aged 12 to 29 years, who have been recently diagnosed (within six months) with Type 1 Diabetes and carry the HLA DR3-DQ2 haplotype, a specific genetic risk factor for the disease. The trial includes further stratification for HLA haplotypes to identify individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8, potentially allowing the identification of a super responder group. HLA testing, which is well-established and widely accessible, facilitates this process.

The DIAGNODE-3 patient population is based on clinical efficacy and safety results from previous Phase 2a and Phase 2b trials, DIAGNODE-1 and DIAGNODE-2. These results are also supported by a large-scale meta-analysis involving data from over 600 individuals from earlier Phase 2 and Phase 3 trials using Diamyd®. The trial design aims to achieve its co-primary endpoints: preserving endogenous insulin production, measured as stimulated C-peptide, and improving blood glucose control, determined by HbA1c levels. Partial funding for DIAGNODE-3 comes from Breakthrough T1D, a leading global Type 1 Diabetes research and advocacy organization.

INNODIA is dedicated to accelerating the development of preventive and curative therapies for Type 1 Diabetes. Its mission is to provide developers with the tools and services needed to effectively halt T1D. INNODIA operates through a dynamic network of academic institutions that specialize in T1D research and treatment. This network is bolstered by the INNODIA People Living with Type 1 Diabetes Community (INPACT), consisting of individuals trained and empowered to support INNODIA’s mission. Additionally, INNODIA sponsors a T1D screening program to identify individuals at stage 1 and 2 of T1D across its clinical sites, enabling immediate participation in preventive clinical trials.

Diamyd Medical focuses on developing precision medicine therapies for preventing and treating Type 1 Diabetes and Latent Autoimmune Diabetes in Adults (LADA). Diamyd® is an antigen-specific immunomodulatory therapy aimed at preserving endogenous insulin production. It has received 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 ongoing DIAGNODE-3 Phase 3 trial is actively enrolling patients with recent-onset Stage 3 Type 1 Diabetes in Europe and the U.S. Previous trials have shown significant results in a large, genetically predefined patient group, where Diamyd® was administered directly into a superficial lymph node in children and young adults. This method, which can be performed in minutes, is designed to optimize the treatment response.

Diamyd Medical is also developing the GABA-based investigational drug Remygen® for metabolic diseases. The company holds significant shares in stem cell company NextCell Pharma AB and artificial intelligence company MainlyAI AB. Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B.