#None #Immunotherapy #Type 1 Diabetes #Diamyd Medical

Transforming Type 1 Diabetes Management

Diamyd Medical is at the forefront of developing groundbreaking therapies for Type 1 Diabetes. In a recent discussion, the company’s Board Member, Professor Mark Atkinson, and CEO, Ulf Hannelius, provided an in-depth look at their recent advancements, specifically focusing on the investigational therapy Diamyd®.

Insights from Company Leaders

In an investor interview, Hannelius highlighted their ambition to not just treat but to also prevent Type 1 Diabetes. As he stated, "We're not just treating Type 1 Diabetes - we're aiming to prevent and cure it." This sentiment reflects the core of Diamyd Medical's mission, which is made even more relevant as adult-onset autoimmune diabetes, or LADA, gains recognition as part of the Type 1 Diabetes spectrum.

The Unique Position of Diamyd®

Diamyd® is a precision immunotherapy designed for patients with a specific HLA genotype related to Type 1 Diabetes. Over 1,000 patients have already undergone treatment with this investigational therapy, confirming its robust safety profile. The therapy works by reprogramming the immune system to preserve insulin production, targeting the root of diabetes instead of merely managing blood sugar levels.

Professor Mark Atkinson praised the therapy's safety, emphasizing, "Diamyd has one of the strongest safety profiles of any drug that I'm aware of seeking to prevent Type 1 Diabetes." He believes the blend of safety and durability makes Diamyd® a compelling option for patients.

A Genetic Match for Optimal Outcomes

Diamyd Medical has developed an innovative therapeutic strategy that matches treatment to individual genetic profiles. Currently, the Phase 3 trial, DIAGNODE-3, is exclusively enrolling patients with the appropriate HLA genotype. Hannelius noted, "With GAD, we target about 40% of Type 1 Diabetics in the Western world. By adding insulin as a second antigen, we can potentially reach 90%."

This potential for broader application suggests that Diamyd® could be integrated as a part of combination therapies without compromising safety, setting it apart from other treatments that pose risks of toxicity or immune system compromise.

Recognizing Adult-Onset Type 1 Diabetes

Diamyd Medical's focus extends beyond newly diagnosed patients to include LADA, or Latent Autoimmune Diabetes in Adults. The acknowledgment by the American Diabetes Association that LADA falls under the Type 1 Diabetes umbrella widens the scope for patient eligibility.

Atkinson remarked, "We believe that it's just a population of slow-progressing individuals with Type 1 Diabetes that happen to occur in adults. Many of these patients are GAD antibody-positive, making Diamyd a unique and optimal drug."

This recognition allows Diamyd Medical the rare opportunity to conduct interventional trials with LADA patients, possessing important safety data extending up to age 70.

A Significant Market Potential

Recent market studies underline the business potential for Diamyd Medical, revealing a projected peak sale potential in the U.S. of up to $2 billion within the Stage 3 Type 1 Diabetes market. By extending their clinical focus to adult-onset Type 1 Diabetes, this market could notably double the commercial opportunity.

Key Milestones on the Horizon

Diamyd Medical plans to achieve critical milestones in the forthcoming months, including results from the pivotal Phase 3 trial DIAGNODE-3, which seek to establish an expedited approval route in the U.S. Hannelius elaborates that this trial has screened over 600 patients to maximize chances for success.

"We've put considerable effort into designing this trial based on past data and genetic considerations, ensuring we've done everything possible to ensure its success," added Atkinson.

Looking Forward to Impact and Adoption

The company is optimistic about the commercial prospective. Hannelius shared that their discussions with U.S. providers and payers have yielded positive feedback, identifying a significant need for such innovative treatments. Atkinson concluded on a hopeful note, stating that this is not merely an investment opportunity; it is a chance to improve lives, prevent disease, and contribute to broader societal health outcomes.

For further insights, the full 60-minute interview can be viewed here.

About Diamyd Medical: Diamyd Medical is dedicated to creating precision medicine therapies aimed at preventing and treating Type 1 Diabetes. Their investigational therapy, Diamyd®, operates specifically for individuals with the HLA DR3-DQ2 gene and is on track to revolutionize the management of this disease.