Diamyd Medical's Phase 3 Trial for Type 1 Diabetes Advances After Final Safety Review

Advancements in Diabetes Treatment: Diamyd Medical’s Phase 3 Trial

Diamyd Medical has recently announced a significant milestone in its clinical research on Type 1 Diabetes. As of November 14, 2025, the independent Data Safety Monitoring Board (DSMB) has completed its sixth scheduled safety review of the DIAGNODE-3 trial, which focuses on the investigational treatment, Diamyd®. This review has confirmed that there are no safety concerns regarding the trial, thus allowing it to proceed as planned towards an interim efficacy readout expected in March 2026.

The DIAGNODE-3 trial, recognized under both Fast Track and Orphan Drug Designations by the U.S. Food and Drug Administration (FDA), is pivotal for Diamyd Medical. Its results could provide the groundwork for a Biologics License Application (BLA) through the FDA's accelerated approval pathway. This swift approval route is essential for bringing innovative treatments to market more quickly, especially for conditions with significant unmet medical needs like Type 1 Diabetes.

Professor Johnny Ludvigsson, the Coordinating Investigator of the DIAGNODE-3 trial, emphasized that the consistent favorable safety profile observed in past studies strengthens the position of Diamyd as a leading candidate in precision medicine for Type 1 Diabetes. Ulf Hannelius, the CEO of Diamyd Medical, expressed optimism about the trial’s potential, highlighting that Diamyd could transform the treatment landscape for Type 1 Diabetes.

Currently, the trial includes a total of 285 enrolled patients, with significant data being gathered from various follow-up stages. Notably, over 70 participants have completed a 24-month follow-up, and more than 135 have reached the 15-month mark. This comprehensive database equips researchers with crucial insights into the efficacy and safety of Diamyd® in a patient population characterized by the HLA DR3-DQ2 genotype, which makes up around 40% of Type 1 Diabetes patients in Europe and the U.S.

Diamyd® represents a notable approach as an antigen-specific immunotherapy aimed at preserving the body’s own insulin production. This innovative treatment targets individuals genetically predisposed to the condition and has been subjected to rigorous evaluations of both safety and effectiveness.

In addition to its groundbreaking trials, Diamyd Medical is also working on developing a biomanufacturing facility in Umeå, Sweden. This facility will produce recombinant GAD65 protein, the active element in the Diamyd® therapy. By enhancing its production capabilities, the company aims to maintain a steady supply of this promising treatment as it progresses through various stages of clinical evaluation.

Moreover, Diamyd Medical holds significant stakes in both NextCell Pharma AB, which specializes in stem cell technologies, and MainlyAI AB, an artificial intelligence company. These partnerships reflect Diamyd's commitment to exploring various avenues in diabetes treatment and prevention, thereby positioning itself as a leader in this critical field.

As the DIAGNODE-3 trial moves closer to its key efficacy readout, anticipation is building across the medical community and among patients alike. The implications of a successful outcome are profound, potentially reshaping treatment strategies for Type 1 Diabetes and offering renewed hope to patients and families affected by this challenging condition. With the March 2026 results on the horizon, all eyes will be on Diamyd Medical as it navigates this critical phase of its development journey.