“The DSMB’s green light following the first safety review is an important step forward in enabling early, personalized treatment of Type 1 Diabetes”, says Ulf Hannelius, CEO of Diamyd Medical. “With over 1,000 individuals already treated with Diamyd® across multiple clinical trials, DiaPrecise adds important new safety data in children and adolescents with presymptomatic Type 1 Diabetes.”
DiaPrecise is the first clinical trial to assess the safety of the targeted administration of Diamyd® in a superficial lymph node in children and adolescents with presymptomatic Type 1 Diabetes (Stage 1 and Stage 2) carrying the genetic profile that has been associated with positive response in previous clinical trials (HLA DR3-DQ2). The trial is a key part of the Diamyd Medical’s strategy to position Diamyd® as a precision immunotherapy capable of delaying - or ideally halting - the onset of clinical (Stage 3) Type 1 Diabetes.
DiaPrecise is conducted under the ASSET program (AI for the Sustainable Prevention of Autoimmunity in Society, www.asset.healthcare), funded by the Swedish Innovation Agency VINNOVA. In parallel, Diamyd Medical is collaborating with DiaUnion, a Nordic cross-border initiative advancing early treatment and screening programs for autoimmune diabetes.
Treating presymptomatic states and incorporating a precision medicine approach reflects a broader shift in diabetes care - from reactive treatment to proactive prevention. With a well-established safety profile, based on a comprehensive database of over 1,000 treated individuals, and a straightforward, minimally invasive injection procedure, Diamyd® is uniquely suited for early-stage use, particularly in children identified through national or regional screening programs. This is supported by a follow-up of a previous prevention trial, DiAPREV-IT, presented at the 2024 ISPAD Congress, suggesting that Diamyd® could delay progression to Stage 3 Type 1 Diabetes by up to seven years in children with Stage 1 or Stage 2 Type 1 Diabetes and HLA DR3-DQ2.
About Diamyd®
Diamyd® (rhGAD65/alum) is an investigational antigen-specific immunotherapy that targets the autoimmune response responsible for destroying insulin-producing cells. It has shown promising results in genetically defined subgroups, particularly those carrying the HLA DR3-DQ2 gene, in both newly diagnosed and presymptomatic Type 1 Diabetes. The same targeted injection method used in DiaPrecise is also being studied in DIAGNODE-3, the company’s pivotal phase 3 trial in patients with recently diagnosed Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 gene. An early readout from DIAGNODE-3 is planned for March 2026, to support a potential accelerated Biologics License Application (BLA) in the United States.
About ASSET
The innovation milieu ASSET (AI for Sustainable Prevention of Autoimmunity in the Society) is an industry-healthcare partnership including Mainly AI, Lund University, Sahlgrenska University Hospital, Örebro University Hospital, The Swedish National Diabetes Register, Leading Health Care Foundation and Diamyd Medical, project coordinator. The project started in September 2021, has a duration of five years, and is financed by the Swedish innovation agency VINNOVA.
ASSET has three main goals: Predict, Prevent and Implement.
Predict: evaluate new algorithms based on Artificial Intelligence (AI) to be able to assess the individual risk of developing Type 1 Diabetes (T1D), and the likelihood of responding to different treatments. Data from cohort studies such as TEDDY (The Environmental Determinants of Diabetes in the Young), from Diamyd Medical's clinical trials with Diamyd® and from sources such as the National Diabetes Registry will constitute the initial training dataset for the algorithm. T1D will form the pilot project for the program, but the goal is extending the functionality to other indications including other autoimmune diseases that are strongly linked to T1D such as celiac disease (gluten intolerance) and autoimmune thyroiditis (inflammatory disease of the thyroid gland).
Prevent: ASSET aims to be a test-bed for clinical development, with the ongoing DiaPrecise trial testing a precision medicine approach to early stage T1D.
Implement: ASSET will study organizational, economic, and legal prerequisites and consequences of applying the approach as a tool for precision health in the Swedish health care system. The goal is to proactively manage obstacles that can slow down the implementation and spread of the innovations in the healthcare system.
Website: https://www.asset.healthcare
About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes. Diamyd® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying a HLA DR3-DQ2 gene. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. An early read-out of the Phase 3 trial is expected in March 2026.Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group – both in a large-scale meta-analysis as well as in the Company’s prospective European Phase IIb trial. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with Type 1 Diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA
Sweden AB is the Company’s Certified Adviser.