STOCKHOLM, Sept. 9, 2024 /PRNewswire/ -- 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.

About Diamyd Medical

Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd^® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd^®. Diamyd Medical also develops the GABA-based investigational drug Remygen^® as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

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