Diamyd Medical's registrational Phase 3 trial DIAGNODE-3 has successfully cleared its final safety review, positioning the precision medicine immunotherapy Diamyd® for a pivotal efficacy readout in March 2026. The independent Data Safety Monitoring Board (DSMB) completed its sixth scheduled safety review, identifying no safety concerns and recommending the trial continue as planned.
The positive safety review strengthens the clinical development pathway for Diamyd®, which operates under both Fast Track and Orphan Drug Designations granted by the U.S. Food and Drug Administration (FDA). Notably, the company has secured an agreement with the FDA that the early efficacy readout planned for March 2026 may serve as the basis for a Biologics License Application (BLA) under the accelerated approval pathway.
Trial Progress and Patient Enrollment
DIAGNODE-3 has enrolled 285 patients to date, demonstrating robust recruitment across 57 clinics in eight European countries and the United States. The trial has achieved significant milestone completions, with more than 70 patients completing the full 24-month follow-up period and over 135 patients completing their 15-month visits.
"The continued favorable safety profile demonstrated in DIAGNODE-3 and earlier studies reinforces Diamyd's position as a leading precision medicine candidate in Type 1 Diabetes," said Professor Johnny Ludvigsson, Coordinating Investigator of DIAGNODE-3.
Precision Medicine Approach
Diamyd® represents an antigen-specific immunomodulatory therapeutic designed for preservation of endogenous insulin production. The treatment specifically targets individuals carrying the HLA DR3-DQ2 gene, which constitutes approximately 40% of patients with Type 1 Diabetes in Europe and the United States. This genetically predefined approach builds on significant results previously demonstrated in preserving endogenous insulin production, both in a large-scale meta-analysis and in the company's prospective European Phase 2b trial.
The DIAGNODE-3 trial exclusively recruits patients with recent-onset (Stage 3) Type 1 Diabetes who carry this common genotype, representing a precision medicine strategy for disease modification.
Regulatory Pathway and Commercial Potential
The FDA has granted Diamyd® Fast Track Designation for both Stage 3 (clinically diagnosed symptomatic) Type 1 Diabetes and Stage 1 and 2 (pre-symptomatic) Type 1 Diabetes, alongside Orphan Drug Designation. This regulatory support, combined with the accelerated approval pathway agreement, positions the therapy for potential rapid market entry following successful efficacy demonstration.
"Diamyd is uniquely positioned among late-stage disease-modifying therapies with the potential to change how Type 1 Diabetes is treated," said Ulf Hannelius, CEO of Diamyd Medical. "We look forward to the Phase 3 interim efficacy readout in March 2026."
Manufacturing and Development Infrastructure
Diamyd Medical is developing a biomanufacturing facility in Umeå, Sweden, for the production of recombinant GAD65 protein, the active ingredient in Diamyd®. This vertical integration strategy supports the company's preparation for potential commercial manufacturing following regulatory approval.
