The analysis was carried out by researchers at Lund University and provides additional support for the application of the therapeutic diabetes vaccine Diamyd^® to prevent or delay clinical type 1 diabetes, and aligns with the rationale of the VINNOVA-financed ASSET project (AI for Sustainable Prevention of Autoimmunity in the Society) coordinated by Diamyd Medical.

“There is growing evidence for the use of the therapeutic diabetes vaccine Diamyd also in prevention, says Ulf Hannelius, CEO of Diamyd Medical. The newly published results are exciting and we are looking forward to advancing our prevention efforts with the diabetes vaccine as part of the ambitious ASSET project alongside our partners. The diabetes vaccine Diamyd is uniquely well positioned to be studied for the prevention of clinical type 1 diabetes considering its strong safety profile and clinical efficacy in recent-onset type 1 diabetes”.

The published immunological results are based on the placebo-controlled randomized clinical trial DiAPREV-IT 2, where the safety and efficacy of subcutaneous GAD-alum (Diamyd^®) was evaluated in healthy children at risk for clinical type 1 diabetes. The immune response at 18 and 24 months following the last GAD-alum injection showed reduced populations of T-lymphocytes compared to placebo-treated individuals, supporting a sustained positive immunomodulatory effect of the diabetes vaccine over the 2-year study period in this study population.

A combined analysis of two prevention trials with subcutaneous GAD-alum (DiAPREV-IT 1 and DiAPREV-IT 2), first announced on September 1, 2020, showed positive trends for an effect of Diamyd^® on delaying the time to type 1 diabetes in children carrying the HLA DR3-DQ2 haplotype. These findings together with the now published immunological results support the rationale of the ASSET innovation milieu coordinated by Diamyd Medical where precision prevention strategies will be evaluated using the diabetes vaccine Diamyd^®. The first clinical trial evaluating intralymphatic administration of Diamyd in individuals at high risk for type 1 diabetes carrying HLA DR3-DQ2 is planned to start in the fourth quarter of 2022.

The publication is titled “Long-Term GAD-alum Treatment Effect on Different T-Cell Subpopulations in Healthy Children Positive for Multiple Beta Cell Autoantibodies” and can be accessed at: https://www.hindawi.com/journals/jir/2022/3532685/

About ASSET
The innovation milieu ASSET (AI for Sustainable Prevention of Autoimmunity in the Society – www.asset.healthcare) 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 extend 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). The prediction algorithm will be evaluated in clinical prevention trials where individuals at high risk for type 1 diabetes will be treated preventively with the diabetes vaccine Diamyd^®. 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 project 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, The Swedish National Diabetes Register, Leading Health Care Foundation and Diamyd Medical, project coordinator.

Website: www.asset.healthcare

About Diamyd Medical
Diamyd Medical develops precision medicine therapies for type 1 diabetes. The diabetes vaccine Diamyd^® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. DIAGNODE-3, a confirmatory Phase III trial is on-going. A vaccine manufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd^®. Diamyd Medical also develops the GABA-based investigational drug Remygen^® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen^® trial in individuals living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders 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; phone: +46 8-528 00 399, e-mail: info@fnca.se

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com

The information was provided by the contact person above, for publication on May 30, 2022, 15.45 CET.