Diamyd Medical’s Pivotal Phase 3 Type 1 Diabetes Trial Clears Final Safety Review Ahead of Early Readout in March 2026

The independent Data Safety Monitoring Board (DSMB) has completed its sixth and final scheduled safety review for Diamyd Medical’s registrational Phase 3 DIAGNODE-3 trial in Type 1 Diabetes, identifying no safety concerns and recommending the trial continue as planned1 9 10.

DIAGNODE-3 is evaluating Diamyd®, a precision medicine immunotherapy targeting individuals with the HLA DR3-DQ2 genotype, which constitutes about 40% of Type 1 Diabetes cases in Europe and the US1 2.

As of the most recent update, 285 patients have been enrolled, with more than 70 having completed the full 24-month follow-up and over 135 completing the 15-month visit1.

The trial aims to preserve endogenous insulin production in newly diagnosed (Stage 3) Type 1 Diabetes patients and could be eligible for accelerated FDA approval if the interim readout expected in March 2026 shows significant benefit1 2 4.

Diamyd® has been granted Orphan Drug and Fast Track Designations by the U.S. FDA for both symptomatic (Stage 3) and pre-symptomatic (Stages 1 and 2) Type 1 Diabetes1 2 3.

The DIAGNODE-3 trial is being conducted in 57–60 centers across eight European countries and the US1 2.

Previous trials and meta-analyses have shown significant preservation of insulin production in genetically selected groups, informing the design and patient selection for DIAGNODE-31 2.

If successful, Diamyd® could become the first precision medicine to change the treatment paradigm for Type 1 Diabetes by addressing the underlying autoimmunity without broad immune suppression1 2.