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Primary endpoints of safety and tolerability were met in Phase II clinical trial GADinLADA, in which diabetes vaccine Diamyd (GAD-alum) was administered directly into lymph node of 14 patients aged 30 to 70 years with autoimmune form of diabetes called LADA.
The results support a precision medicine approach with Diamyd® where significant effect on the preservation of endogenous insulin producing capacity and improved blood glucose control was seen in individuals that carry a specific genotyp, HLA DR3-DQ2.
The patients, diagnosed with type 1 diabetes, have been given the diabetes vaccine Diamyd® directly into the lymph node on three occasions, one month apart, in combination with oral vitamin D (or its placebo) during four months, starting 30 days prior to the first injection.
All 50 patients who participated in the extension of Diamyd Medical's Phase IIb trial DIAGNODE-2 with the diabetes vaccine Diamyd® have now made their 24-month visit, and data will be presented in early July.
Lead Product(s):
Recombinant human glutamic acid decarboxylase,Vitamin D
The clinical Phase II trial GADinLADA, where the diabetes vaccine Diamyd® is administered directly into the lymph node in patients with the autoimmune form of diabetes LADA, is fully recruited, and the first results from the trial are planned to be announced in 2022.
Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a genetically predefined patient group in a large-scale meta-analysis as well as in the Company’s European Phase IIb trial DIAGNODE-2.
The trial is designed to confirm the effect and safety of Diamyd® in individuals recently diagnosed with type 1 diabetes who carry the genetic HLA DR3-DQ2 haplotype.
Results from the phase IIb trial DIAGNODE-2 with intralymphatic administration of Diamyd® and meta-analysis comprising data from more than 600 patients treated with Diamyd® showing treatment effect in individuals carrying the HLA DR3-DQ2 haplotype, will be presented.
The immunological findings indicate early treatment-specific immune responses that may associate with HLA type and clinical treatment response to Diamyd®.
Diamyd Medical's Phase IIb trial DIAGNODE-2 with the diabetes vaccine Diamyd is expected to present Topline results at the end of September. All patients in the trial where Diamyd® is given directly into the lymph node have completed their 15-month visits according to plan.