Swedish biotech Diamyd has received Fast Track designation from the US Food and Drug Administration (FDA) for its eponymous type 1 diabetes immunotherapy Diamyd (rhGAD65/alum).
Diamide Antigen-specific immunotherapy to preserve insulin-producing beta cells. It is being developed as a treatment to improve glycemic control in patients with type 1 diabetes who carry the HLA DR3-DQ2 genotype, a gene associated with increased susceptibility to insulin-dependent diabetes.
This treatment is being evaluated in the randomized, placebo-controlled Phase III DIAGNODE-3 trial (NCT05018585). The study will enroll approximately 330 participants between the ages of 12 and 28 who have recently been diagnosed with type 1 diabetes and carry the HLA DR3-DQ2 gene. The primary endpoints of this trial include base blood glucose levels measured using hemoglobin A1c (HBA1c) and stimulated C-peptide during a mixed meal tolerance test (MMTT) to check how well beta cells are functioning. Includes evaluation of 24-month changes compared to line.
Although the trial suffered a setback when the U.S. FDA placed a partial hold on clinical trials for approximately 14 months beginning in September 2021, clinical trial recruitment and treatment continued across sites in Europe. Enrollment for this trial is expected to be completed in the second half of this year, according to the company’s 2024 financial report.
Diamide is also being studied as a preventive therapy for children with the HLA DR3-DQ2 genotype who are at risk of developing type 1 diabetes. The DiaPrecise open-label trial (2022-002356-39) is being conducted in partnership with the Swedish research center DiaUnion. The study will enroll approximately 16 prediabetic patients between the ages of 8 and 18 with the HLA DR3-DQ2 genotype.
The burden of type 1 diabetes is predicted to increase in the coming years.a modeling research The prevalence of type 1 diabetes is estimated to be approximately 13.5 to 17.4 million people in 2040. In 2022, the US FDA will The first and only treatment to delay disease onset Type 1 diabetes, Prevention Bio’s Tzield (teplizumab). In response, Diamid CEO Ulf Hanelius said the approval of ZIELD “clarifies the regulatory pathway for disease-modifying therapies in type 1 diabetes and sets standards in the field for pricing and reimbursement.” ” said in a press release on November 18, 2022.
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