Diamyd Medical is invited as a speaker at the 7th Antigen Specific Immune Tolerance summit to be held in Boston, MA, on March 18-20, 2024. CEO Ulf Hannelius will present up-to-date HLA haplotype frequency data in Type 1 Diabetes collected as part of the ongoing precision medicine Phase 3 trial DIAGNODE-3. The antigen-specific immunotherapy Diamyd® was recently, as previously announced, awarded Fast Track designation by the FDA. The presentation is titled Decoding the Future: Leveraging Biomarkers in Antigen-Specific Immunotherapy for Type 1 Diabetes, and will focus on the latest insights from genetic HLA typing in the DIAGNODE-3 Phase 3 trial and its potential for the future of diabetes care including screening efforts and personalized treatments.

The antigen-specific immunotherapy Diamyd® was recently, as previously announced, awarded Fast Track designation by the U.S. FDA to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2. The HLA data analysis, based on 239 individuals with Type 1 Diabetes screened within the framework of the DIAGNODE-3 trial as of January 9, 2024, confirms that about 50% of all the screened individuals carry the HLA DR3-DQ2 haplotype that has been associated with a positive response to Diamyd® treatment. Also as expected, up to 40% of screened patients fulfill all inclusion criteria for the study.

In addition, the data show that 53% of all screened male patients carry the DR3-DQ2 haplotype compared to 45% of all screened female patients. This finding is in line with insights from previous clinical trials with Diamyd® and suggests that in the studied age group of 12- to 29-year-olds, the DR3-DQ2 haplotype is more common in male patients with Type 1 Diabetes compared to female patients.