Swedish biotech Diamyd has won a fast track designation for its eponymous type 1 diabetes immunotherapy  Diamyd (rhGAD65/alum) from the US Food and Drug Administration (FDA).

Diamyd is an antigen-specific immunotherapy for the preservation of beta cells, which produce insulin. It is being developed as a therapy for improving glycaemic control in type 1 diabetics with the HLA DR3-DQ2 genotype – a gene associated with increased susceptibility to insulin-dependent diabetes.

The therapy is being evaluated in a randomised, placebo-controlled Phase III DIAGNODE-3 trial (NCT05018585). The study is expected to enrol approximately 330 participants ages 12–28 years who were recently diagnosed with type 1 diabetes and carry the HLA DR3-DQ2 gene. The trial’s primary endpoints include evaluating a change in blood glucose levels measured using haemoglobin A1c (HBA1c) and stimulated C-peptide during a mixed meal tolerance test (MMTT) that checks how well the beta cells are working, at 24 months compared to baseline.

The trial suffered a setback when the US FDA placed a partial clinical hold on the trial for approximately 14 months starting September 2021, but the trial did continue recruitment and treatment across its European sites. The trial is expected to complete enrolment in H2 of this year, as per the company’s 2024 financials.

Diamyd is also being investigated as a preventive therapy for children with the HLA DR3-DQ2 genotype who are at risk of developing type 1 diabetes. The open-label DiaPrecise trial (2022-002356-39) is being conducted in partnership with a Swedish research centre DiaUnion. The study will enrol approximately 16 pre-diabetic participants ages 8–18 years with HLA DR3-DQ2 genotype.

The burden of type 1 diabetes is forecasted to increase in the coming years. A modelling study estimated the prevalence of type 1 diabetes to be approximately 13.5–17.4 million in 2040. In 2022, the US FDA approved the first and only treatment to delay the onset of type 1 diabetes, Provention Bio’s Tzield (teplizumab). Following this, Diamyd’s CEO Ulf Hannelius noted the Tzield approval “creates clarity around the regulatory pathway for disease-modifying therapies in type 1 diabetes and will set a reference for the field regarding pricing and reimbursement,” in a 18 November 2022 press release.

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