Diamyd Medical

"We are experiencing a paradigm shift in medicin," says Hans Winberg, Secretary General, Leading Healthcare Foundation. "We see however only a few signs of this in our current health care system. We need to develop the infrastructure and operational processes to be able to handle the groundbreaking innovations in medical and digital technology that are now occuring. The ASSET workshop is a step forward in that development."

In Sweden, about 1,000 children are diagnosed with type 1 diabetes each year. The disease is life-threatening and carries severe complications later in life. Advances in understanding of type 1 diabetes make it possible to detect the disease in its latent phase and administer treatments that modify disease progression. Applying a precision prevention approach to type 1 diabetes requires screening for early signs of the disease, implying a new paradigm for healthcare systems to manage early diagnosis and monitoring of affected individuals.

"Type 1 diabetes is spearheading preemptive medicine," says Ulf Hannelius, CEO of Diamyd Medical. "To integrate predictive analytics with targeted immunotherapies like the antigen-specific immunotherapy Diamyd holds the potential to prevent symptomatic disease. This requires strong engagement with relevant stakeholders, and the ASSET partnership provides the nescessary platform to bring this vision to fruition."

About ASSET
The innovation milieu ASSET (AI for Sustainable Prevention of Autoimmunity in the Society) will develop and 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 consitute 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). In parallel, 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. The project, which started in September 2021, has a duration of five years and is financed via the Swedish innovation agency VINNOVA.

The ASSET consortium consists of Mainly AI, Lund University, Sahlgrenska University Hospital, Örebro University Hospital, The Swedish National Diabetes Register, Leading Health Care Foundation and Diamyd Medical, project coordinator.

Website: https://www.asset.healthcare

About Diamyd Medical
Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation (Feb-2024) by the U.S. FDA. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd^® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and is intended to optimize the immune response. 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 also develops the GABA-based investigational drug Remygen^® as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB as well as 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.