Diamyd Medical's Innovative Path to Type 1 Diabetes Treatment

Diamyd Medical Pursues Accelerated FDA Approval

Diamyd Medical is taking significant strides in the pursuit of an accelerated approval pathway in the U.S. for its innovative antigen-specific immunotherapy, Diamyd (rhGAD65/alum). This groundbreaking treatment aims to preserve the body's ability to produce insulin in those diagnosed with Stage 3 Type 1 Diabetes.

Study Insights and Future Steps

The company is relying on findings from an interim readout of the ongoing Phase 3 trial, known as DIAGNODE-3, as a crucial component for its Biologics License Application (BLA). This interim data is anticipated to illuminate key aspects of Diamyd's efficacy and could pave the way for quicker patient access to this promising therapy.

Interim Study Readout Timeline

Results from this critical analysis are expected to emerge around March 2026. Ulf Hannelius, CEO of Diamyd Medical, emphasizes the urgency behind this effort. He states, "We are committed to working diligently alongside our partners and the FDA to expedite Diamyd's availability for patients, as the interim findings from DIAGNODE-3 signify a pivotal step for us. Our positive outlook is further reinforced by the favorable results from a recent futility analysis."

Understanding Accelerated Approval Pathways

The U.S. FDA has acknowledged that Diamyd could receive accelerated approval based on evidence showcasing significant treatment-related improvements in C-peptide levels—a key marker of the body's insulin production—following treatment with Diamyd. Accelerated approval allows vital medications for serious conditions to hit the market sooner when they demonstrate significant benefits via surrogate endpoints.

Preparing for BLA Submission

As part of the preparation for the BLA under the FDA's Accelerated Approval Program, Diamyd Medical is currently conducting detailed assessments, analyzing data from roughly 170 participants who have completed their 15-month assessment. This includes safety data from additional participants in the DIAGNODE-3 trial, further solidifying their evidence base.

Details of the DIAGNODE-3 Trial

Planned to enroll around 330 patients by the end of 2025, the DIAGNODE-3 trial operates across eight European countries and the U.S., focusing primarily on patients recently diagnosed with Stage 3 Type 1 Diabetes. Notably, it targets individuals with the HLA DR3-DQ2 genotype—a specific subgroup shown to have a positive response to Diamyd in prior studies.

About Diamyd Medical

Diamyd Medical is dedicated to developing precise therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd (rhGAD65/alum) is recognized for potentially preserving endogenous insulin production and has received Orphan Drug Designation as well as Fast Track Designation from the FDA for treating various stages of Type 1 Diabetes. The company is currently running the confirmatory Phase III trial, DIAGNODE-3, actively recruiting participants in multiple countries, including the U.S.

Key Developments and Future Outlook

Recent results from large-scale meta-analyses and the company’s Phase IIb trial have illustrated promising outcomes for Diamyd. The approach of injecting directly into a lymph node allows for efficient treatment delivery, optimizing patient responses. Furthermore, Diamyd Medical is working on establishing a biomanufacturing facility in Umeå, Sweden, aimed at producing recombinant GAD65 protein—the active component of Diamyd.

Contact Information

For more information, contact Ulf Hannelius, the President and CEO. You can reach him at +46 736 35 42 41. Diamyd Medical’s B-share is traded on the Nasdaq First North Growth Market under the ticker DMYD B, with FNCA Sweden AB serving as the Certified Adviser.

Frequently Asked Questions

What is Diamyd Medical pursuing with its therapies?

Diamyd Medical is focused on an accelerated approval pathway for its immunotherapy treatment for Type 1 Diabetes.

What study is central to Diamyd's approval process?

The DIAGNODE-3 trial serves as a fundamental study from which interim results will be used for regulatory approval.

How does accelerated approval work?

Accelerated approval allows drugs to be approved based on early evidence that suggests they are likely to provide a clinical benefit.

What is the main objective of the DIAGNODE-3 trial?

The trial aims to evaluate the efficacy and safety of Diamyd in recently diagnosed patients with Type 1 Diabetes.

How can I reach Diamyd Medical for inquiries?

You can contact Ulf Hannelius, the CEO, at +46 736 35 42 41 for further information.

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