Diamyd Medical has secured FDA alignment to fast-track the primary efficacy readout in its pivotal Phase 3 DIAGNODE-3 trial, cutting the timeline from 24 months to 15 months. The move, guided by FDA feedback, allows the company to deliver full trial results nine months earlier than previously planned. 

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026 and could support an accelerated Biologics License Application (BLA) pathway. 

"We are very pleased with the FDA's feedback as it provides a clear way forward," said Ulf Hannelius, CEO of Diamyd Medical.  

"The proposed change meaningfully shortens the timeline to the full primary efficacy readout in our registrational Phase 3 trial, while maintaining a robust assessment of long-term efficacy. We remain focused on the upcoming interim efficacy readout in March 2026, which is on track as the next key catalyst in our efforts to bring this therapy to patients with type 1 diabetes." 

The DIAGNODE-3 trial’s co-primary endpoints—C-peptide area under the curve (AUC), a marker of endogenous insulin production, and HbA1c, a measure of blood sugar control—were originally set at 24 months.  

Following a recent Type C meeting, the FDA agreed to move the primary efficacy assessment to 15 months, with the 24-month evaluation retained as a secondary endpoint to assess treatment durability.

DIAGNODE-3 is a randomized, double-blind, placebo-controlled Phase 3 study testing Diamyd in approximately 300 genetically defined patients with Stage 3 type 1 diabetes. Diamyd is a precision-medicine, antigen-specific immunotherapy aimed at preserving endogenous insulin production. 

The FDA has granted Diamyd Fast Track Designation for Stages 1–3 of type 1 diabetes, Orphan Drug Designation for Stage 3, and confirmed C-peptide as an acceptable surrogate endpoint for potential accelerated approval in the US.