Diamyd Medical Aligns with FDA on Key Elements for an Accelerated Approval Process

STOCKHOLM, Dec. 13, 2024 /PRNewswire/ -- Diamyd Medical today announced a positive in-person Type C meeting with the U.S. Food and Drug Administration (FDA), where alignment was achieved on key components of the planned early readout and an accelerated approval pathway for the antigen-specific immunotherapy, Diamyd (rhGAD65/alum). Additional details of the FDA interaction will be disclosed upon receipt of the final meeting minutes, expected in January 2025.

"We are very pleased with the positive and constructive dialogue and the alignment achieved with the FDA on key elements of the accelerated readout procedure," says Ulf Hannelius, CEO of Diamyd Medical. "This represents a significant milestone as we advance toward making Diamyd available to patients with Type 1 Diabetes needing disease-modifying treatments. Importantly, the accelerated approval pathway could allow Diamyd to reach the market more than a year earlier, addressing the urgent need for innovative therapies."

The early readout, planned for March 2026 for the ongoing Phase 3 DIAGNODE-3 trial, will include approximately 170 evaluable participants who have completed their 15-month assessment. As of today, 191 patients have been randomized in the trial. This analysis will provide efficacy data based on preservation of C-peptide levels, which the FDA, following a Type C meeting held in July 2024 with Diamyd Medical, recognizes as a surrogate endpoint reasonably likely to predict clinical benefit in Type 1 Diabetes, and can therefore be used to obtain Accelerated approval.

About Diamyd Medical

Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd has also been granted Fast Track Designation for the treatment of Stage 1 and 2 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics 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: [phone]
E-mail: [e-mail]

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