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Diamyd Medical Advances Type 1 Diabetes Precision Medicine via Accelerated Approval Pathway

NextEdge Admin

10 Sep 2024

2 min 45 sec

Diamyd Medical is pursuing an accelerated approval pathway in the U.S. for its antigen-specific immunotherapy, Diamyd® (rhGAD65/alum), aimed at preserving endogenous insulin production in patients with Stage 3 Type 1 Diabetes. The decision follows a positive futility analysis and is supported by the FDA's Fast Track designation, granted earlier. Diamyd® targets a specific subgroup of patients with the HLA DR3-DQ2 genotype, comprising approximately 40% of those with Stage 3 Type 1 Diabetes, who have shown a positive response to the therapy in prior trials.

The ongoing Phase 3 trial, DIAGNODE-3, will serve as the foundation for a Biologics License Application (BLA) under the FDA's Accelerated Approval Program. An interim study readout, expected in March 2026, will provide efficacy data from around 170 participants who have completed 15-month assessments and safety data from additional enrollees. The primary endpoint of this analysis will be C-peptide levels, a surrogate marker for endogenous insulin production, which the FDA has recognized as reasonably likely to predict clinical benefit. Following the interim readout, the trial will continue until all patients complete their 24-month assessments. Full enrollment of 330 patients is expected by the end of 2025.

CEO Ulf Hannelius stated, “We are committed to working closely with the FDA to seize this opportunity and make Diamyd® available to patients as quickly as possible.” The FDA’s Accelerated Approval Program allows for faster approval based on surrogate endpoints in cases of serious conditions with unmet medical needs.

Conducted across eight European countries and the U.S., the DIAGNODE-3 trial aims to deliver a potentially disease-modifying therapy for Type 1 Diabetes, focusing on preserving the body's ability to produce insulin and improving long-term patient outcomes.