Diamyd Medical is making significant strides in the fight against Type 1 Diabetes (T1D) with its antigen-specific immunotherapy, Diamyd®. This therapy targets individuals carrying the HLA DR3-DQ2 genotype, a genetic marker present in approximately 40% of newly diagnosed T1D patients.
The ongoing Phase 3 trial, DIAGNODE-3, is evaluating the efficacy of Diamyd® in preserving the body’s insulin-producing capacity. The DIAGNODE-3 trial is enrolling up to 330 participants aged 12 to 29 years who have been diagnosed with T1D within the past six months and carry the HLA DR3-DQ2 haplotype.
This study builds upon previous Phase 2 trials and a meta-analysis involving over 600 individuals, which indicated a potential benefit of Diamyd® in this specific genetic subgroup. In a novel approach, Diamyd® is administered directly into a lymph node, aiming to modulate the immune response more effectively.
This method is designed to preserve endogenous insulin production, potentially improving blood sugar control and reducing the risk of long-term complications associated with T1D.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Diamyd® for treating T1D in patients with the HLA DR3-DQ2 genotype, recognizing the therapy’s potential to address an unmet medical need.
An interim analysis of the DIAGNODE-3 trial is expected around March 2026, which may support an accelerated approval pathway for Diamyd®. Diamyd Medical’s focus on precision medicine represents a promising advancement in T1D treatment, offering hope for therapies tailored to individual genetic profiles.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Please consult a healthcare professional for personalized medical guidance. Medosis Health does not endorse any specific product, treatment or company mentioned herein.
