”These presentations highlight our data-driven strategy in preventing and treating type 1 diabetes, emphasizing the critical role of a precision medicine approach based on genetics”, says Ulf Hannelius, CEO of Diamyd Medical. “By targeting those who are most likely to benefit from Diamyd^® immunotherapy, we can make a meaningful impact on patient treatment outcomes”.

Poster Presentations at ISPAD 2024
At ISPAD, two poster presentations will showcase Diamyd Medical’s precision medicine approach to clinical development of the Diamyd^® immunotherapy:

1. “A Follow-Up on the Randomized, Placebo-Controlled Clinical Trial DIAPREV-IT Evaluating the Effect of GAD-Alum on the Progression to Type 1 Diabetes in Children with Multiple Islet Cell Autoantibodies” 

   - Lead Author: Professor Helena Elding Larsson (Malmö, Sweden) 

This abstract reports results from a follow-up study of the DiAPREV-IT trial investigating whether two subcutaneous injections of Diamyd^® (GAD-alum) could delay the onset of Stage 3 Type 1 Diabetes in children with multiple autoantibodies. While the study is based on a limited number of data points, results indicate that, although not reaching statistical significance, Diamyd^® may delay the progression from Stage 1 or Stage 2 to Stage 3 Type 1 Diabetes, by up to 7-years in children carrying HLA DR3-DQ2 haplotype. Also, no treatment effect is observed in children negative for HLA DR3-DQ2, reinforcing the potential benefit and importance of a precision medicine approach.

2. “Exploring HLA Genotype Variations in Type 1 Diabetes: Implications for Precision Medicine and Immunotherapy Response” 

   - Lead Author: Professor Johnny Ludvigsson (Linköping, Sweden) 

This analysis examines the variation in frequency of HLA DR3-DQ2 genotype across different geographic regions, as well as age and gender, in several trials testing the immunotherapy Diamyd^®. The results show a high prevalence of the HLA DR3-DQ2 haplotype across Europe and in the U.S., with variations reflecting the complex interplay between geography, age and gender of Type 1 Diabetes. These results provide key insights into the heterogeneity of Type 1 Diabetes and the necessity of a precision medicine approach in future treatments.

Oral Presentation at IDS 2024 Satellite Symposium
At IDS 2024, Diamyd Medical will participate in a Satellite Symposium organized by Abbott, with the following invited presentation:

“Clinical Study Results of Diamyd^® Antigen-Specific Immunotherapy to Preserve ß-Cell Function and Improve Glycemic Control in Type 1 Diabetes Patients with HLA DR3-DQ2” 

   - Speaker: Anton Lindqvist, Chief Scientific Officer, Diamyd Medical 

This presentation will focus on how Diamyd^® immunotherapy improves glycemic control in patients carrying the HLA DR3-DQ2 genotype. Using glycemic measures based on HbA1c and continuous glucose monitoring, the presentation showcases the therapeutic potential and clinical benefit of Diamyd^® in preserving endogenous insulin production.

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 by the U.S. FDA for the treatment of Stage 1, 2 and 3 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. 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 are intended to optimize the treatment 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 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.

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 October 14, 2024, 08:45 CET.