Diamyd Medical will pursue 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. An earlier interim study readout from the ongoing Phase 3 trial, DIAGNODE-3, is planned to serve as the basis for a Biologics License Application (BLA) under the accelerated approval pathway. Results from the interim readout are expected around March 2026.

“We are committed to working at full speed with our partners and in close dialogue with the FDA to seize this unprecedented opportunity of making Diamyd® available to patients as quickly as possible,” says Ulf Hannelius, CEO of Diamyd Medical. “The earlier readout from the DIAGNODE-3 trial represents a critical step in this process and our confidence in Diamyd®’s disease-modifying benefits is boosted by the positive outcome of the recently announced futility analysis.  We look forward to working closely with the FDA to ensure that all necessary regulatory requirements are met.”

Diamyd Medical recently announced Fast track designation in the U.S. for Diamyd®, and that the U.S. Food and Drug Administration (FDA) has acknowledged that accelerated approval could be sought based on a demonstration of significant treatment-related benefits on C-peptide levels, a measure of endogenous insulin production, in response to Diamyd® administration. The FDA’s Accelerated approval program allows drugs for serious conditions that fills an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint allows the FDA the potential to approve these drugs faster.

To prepare the BLA under the FDA's Accelerated Approval Program, Diamyd Medical plans to conduct an interim study readout, including efficacy data from approximately 170 participants who have completed their 15-month assessment and safety data from additional individuals enrolled in the DIAGNODE-3 trial. The primary endpoint for this analysis will be C-peptide, a surrogate endpoint now recognized by the FDA as reasonably likely to predict clinical benefit. Following the interim readout, the DIAGNODE-3 trial will continue to follow all enrolled patients until the 24-month end-of-study assessment. To date, 148 patients have been randomized in DIAGNODE-3. The results of the interim study readout are expected around March 2026, the exact time depending on the final number of participants to be included in the readout, followed by submission of a BLA under the accelerated approval pathway

The DIAGNODE-3 trial, which is being conducted in eight European countries and the United States, is expected to fully recruit approximately 330 patients by the end of 2025, and all patients are expected to be fully treated before the time the earlier readout is to be performed. The trial focuses on recently diagnosed patients with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype; a subgroup of approximately 40% of Stage 3 Type 1 Diabetes patients that has been shown to respond to Diamyd® in previous trials.

 

Source: diamyd.com

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