Diamyd Medical announced that it has reached alignment with the U.S. Food and Drug Administration to accelerate the primary efficacy readout in its ongoing pivotal, registrational Phase 3 DIAGNODE-3 trial in type 1 diabetes. Based on FDA guidance, the primary readout will now occur at 15 months instead of 24 months, enabling results to be available nine months earlier than previously planned and communicated.
The previously announced interim efficacy readout, involving approximately 170 participants with 15-month data, remains on track for the end of March 2026. This interim analysis may support an accelerated Biologics License Application (BLA) pathway, consistent with FDA guidance.
The trial's co-primary efficacy endpoints—C-peptide area under the curve (AUC), a marker of endogenous insulin production, and HbA1c, a measure of blood sugar control—were originally defined at 24 months. Following a recent Type C meeting, and in line with FDA guidance, the FDA agreed with the company's proposal to shift the primary efficacy readout to 15 months. A formal protocol amendment will be submitted for FDA review.
The originally planned 24-month assessment will remain in place as a secondary endpoint, designed to evaluate the durability of Diamyd's treatment effect.
DIAGNODE-3 is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating Diamyd in approximately 300 genetically defined individuals with Stage 3 type 1 diabetes. Diamyd is a precision-medicine, antigen-specific immunotherapy designed to preserve endogenous insulin production.
The FDA has granted Fast Track Designation for Diamyd across Stages 1-3 of type 1 diabetes, Orphan Drug Designation for Stage 3 type 1 diabetes, and has confirmed C-peptide as an acceptable surrogate endpoint that may support an accelerated approval pathway in the United States.
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