Diamyd Medical has reached alignment with the US Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, registrational phase III DIAGNODE-III trial in type I diabetes from 24 to 15 months, as per the Food and Drug Administration (FDA) guidance, enabling the full primary efficacy readout of the trial to occur 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 and may support an accelerated BLA pathway, consistent with FDA guidance.

"We are very pleased with the FDA's feedback as it provides a clear way forward. The proposed change meaningfully shortens the timeline to the full primary efficacy readout in our registrational phase III 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 I diabetes," said Ulf Hannelius, CEO, Diamyd Medical.

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 consistent with FDA guidance, the FDA agreed with the company's proposal to change the timepoint for the primary efficacy readout to 15 months, with a formal protocol amendment to be submitted for FDA review. The originally planned 24-month assessment will be retained as a secondary endpoint to assess durability of the treatment effect of Diamyd.

DIAGNODE-III is a randomised, double-blind, placebo-controlled phase III trial evaluating Diamyd in approximately 300 genetically defined individuals with stage III type I 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 one to three of type I diabetes, Orphan Drug Designation (ODD) for stage III type I diabetes, and has confirmed C-peptide as an acceptable surrogate endpoint that may support an accelerated approval pathway in the US.