Diamyd Medical's Innovative Pathway for Diabetes Treatment

Diamyd Medical's Strategic Approach to Type 1 Diabetes

Diamyd Medical is embarking on a promising journey to seek accelerated approval in the U.S. for its groundbreaking immunotherapy, Diamyd (rhGAD65/alum). This specific treatment is engineered to preserve the body’s natural insulin production in individuals diagnosed with Stage 3 Type 1 Diabetes. As part of this approach, the company intends to use an interim study readout from its ongoing Phase 3 trial, DIAGNODE-3, to support a Biologics License Application (BLA) under the accelerated approval initiative.

Commitment to Patients and Regulatory Engagement

Ulf Hannelius, CEO of Diamyd Medical, emphasizes the company’s commitment to advancing this treatment swiftly. In his words, "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." This interim readout from the DIAGNODE-3 trial is seen as a pivotal milestone, especially after a positive futility analysis recently concluded.

Benefits of Accelerated Approval

Diamyd Medical has achieved Fast Track designation in the U.S. for Diamyd, with the FDA recognizing the potential for accelerated approval, should significant treatment-related improvements on C-peptide levels be demonstrated. C-peptide serves as a vital indicator of endogenous insulin production. With the FDA's Accelerated Approval Program, there lies an opportunity for faster drug approvals for serious conditions, provided a surrogate endpoint is established.

Preparing for the Future

To pave the way for the BLA as part of the FDA’s Accelerated Approval Program, Diamyd Medical is set to conduct an interim study readout involving efficacy data from about 170 participants who have completed their assessment period, along with safety data from other DIAGNODE-3 trial participants. The primary objective for this analysis will focus on measuring C-peptide levels. The trial is structured to ensure continuous monitoring of all participants until the 24-month end-of-study evaluation.

The DIAGNODE-3 Trial: An Overview

The DIAGNODE-3 trial is a significant undertaking, spread across eight European countries and the United States, aiming for a total enrollment of approximately 330 patients by the end of 2025. This trial prioritizes recently diagnosed patients with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype—a subgroup known to respond positively to Diamyd treatment in previous studies.

About Diamyd Medical

Diamyd Medical is dedicated to advancing precision medicine solutions aimed at preventing and treating Type 1 Diabetes and Latent Autoimmune Diabetes in Adults (LADA). The company's immunotherapy, Diamyd, is an antigen-specific immunomodulatory treatment that works to maintain the body’s natural insulin production and has received Orphan Drug Designation and Fast Track status from the FDA for various stages of Type 1 Diabetes. Furthermore, the DIAGNODE-3 trial is actively recruiting patients diagnosed with recent-onset (Stage 3) Type 1 Diabetes across eight European countries and the U.S.

Innovative Treatment Methods

Evidence from prior large-scale meta-analyses and a European Phase IIb trial revealed promising outcomes when Diamyd was administered directly into a lymph node in young individuals with recent Type 1 Diabetes diagnoses. This method allows for optimized treatment responses, a key factor in enhancing patient outcomes.

Future Developments

A biomanufacturing facility is being constructed in Umeå, Sweden, to enable the production of recombinant GAD65 protein, the active component in Diamyd’s immunotherapy. Additionally, Diamyd Medical is developing a GABA-based investigational drug, Remygen, targeting metabolic disorders. The company is also a significant shareholder in ventures like NextCell Pharma AB and MainlyAI AB, highlighting its commitment to pushing the boundaries of medical science.

Get in Touch for More Information

If you want to learn more about Diamyd Medical's advancements in Type 1 Diabetes treatment, feel free to reach out directly to Ulf Hannelius, President and CEO, at +46 736 35 42 41.

Frequently Asked Questions

What is the main objective of Diamyd Medical's research?

The primary goal is to seek accelerated approval for its immunotherapy, Diamyd, to preserve insulin production in patients with Type 1 Diabetes.

How does the accelerated approval process work?

This process allows for faster approval of drugs for serious conditions based on early evidence of clinical benefits, particularly through surrogate endpoints like C-peptide levels.

What is the significance of the DIAGNODE-3 trial?

DIAGNODE-3 is pivotal as it evaluates the effectiveness of Diamyd in a specific patient population, crucial for supporting their BLA application.

Where is Diamyd Medical’s biomanufacturing facility located?

The facility is being developed in Umeå, Sweden, to manufacture the active ingredient in Diamyd.

Who can I contact for more information about Diamyd Medical?

For inquiries, you can contact Ulf Hannelius, President and CEO, directly by phone at +46 736 35 42 41.

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