Diamyd Medical's DIAGNODE-3 Trial Exceeds Recruitment Target, Anticipates Early Readout

• Diamyd Medical's DIAGNODE-3 Phase 3 trial, evaluating Diamyd® for Type 1 Diabetes, has reached its initial recruitment target of 180 patients.
• This milestone supports an early data readout expected around March 2026, potentially enabling an accelerated Biologics License Application (BLA) submission.
• The trial assesses Diamyd®'s ability to preserve endogenous insulin production in a genetic subgroup of individuals with newly diagnosed Stage 3 Type 1 Diabetes.
• DIAGNODE-3 is continuing recruitment to reach a total of approximately 330 patients to ensure comprehensive data collection over 24 months.

Diamyd Medical has announced that its DIAGNODE-3 Phase 3 trial has reached a significant recruitment milestone, enrolling 180 patients. This achievement surpasses the initial target set for the planned early readout, which is anticipated in March 2026. The data from this readout is intended to support a potential accelerated Biologics License Application (BLA) with the FDA.

Ulf Hannelius, CEO of Diamyd Medical, stated, "We are proud to have reached the 180-patient milestone, which is critical for the planned accelerated readout. This progress reflects the engagement and the strong support from our clinical sites and the Type 1 Diabetes community in advancing innovative, precision-based therapies."

DIAGNODE-3 Trial Details

DIAGNODE-3 is a precision medicine trial evaluating Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes who carry the HLA DR3-DQ2 haplotype. The trial is designed to assess the preservation of endogenous insulin production, measured by C-peptide levels, and glycemic control, assessed by HbA1c levels. The trial will continue recruiting to reach a total of approximately 330 patients who will be followed for 24 months.

The trial builds upon previous clinical data that suggests Diamyd® has the potential to preserve beta cell function in individuals with Type 1 Diabetes, particularly those within the specified genetic subgroup. Diamyd® has been granted Fast Track designation by the FDA for the treatment of Stage 1, 2, and 3 Type 1 Diabetes. In July of this year, the FDA acknowledged C-peptide as a reasonably likely surrogate endpoint that can be used to support accelerated approval for Diamyd®.

Diamyd Medical's Focus

Diamyd Medical is focused on developing precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is designed to modulate the immune system and preserve endogenous insulin production. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in Diamyd®.