Swedish clinical-stage diabetes company Diamyd Medical (STO:DMYD-B) announced on Tuesday that it has received positive feedback from the US Food and Drug Administration (FDA) about an Accelerated Approval pathway for its immunotherapy, Diamyd, targeting Stage 3 Type 1 Diabetes patients with the HLA DR3-DQ2 genotype.

During a recent Type C Meeting, the FDA agreed that C-peptide could be used as a surrogate endpoint to predict the clinical benefit of preserving endogenous insulin production. This acknowledgment opens the possibility for Accelerated Approval based on significant treatment-related improvements in C-peptide levels due to Diamyd administration.

Ongoing discussions between Diamyd Medical and the FDA will clarify the requirements for a Biologics License Application (BLA) under this pathway, including an earlier readout from the ongoing Phase 3 DIAGNODE-3 trial.

Diamyd Medical focuses on precision medicine therapies for Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd has received Orphan Drug Designation and Fast Track Designation from the FDA for treating Stage 1, 2, and 3 Type 1 Diabetes.

The DIAGNODE-3 Phase III trial is currently recruiting patients with recent-onset Stage 3 Type 1 Diabetes in the US and eight European countries.