Diamyd Medical shares insights on precision medicine-based Type 1 Diabetes treatment.

Diamyd Medical, a company developing precision medicine-based treatments for Type 1 Diabetes, is positioning its investigational therapy Diamyd® as a disease-modifying and preventive treatment. The therapy has a strong safety profile and targets specific genetic markers. The company is expanding into the adult-onset autoimmune diabetes (LADA) segment, which is increasingly recognized as part of the Type 1 Diabetes spectrum, doubling the potential market. A registrational Phase 3 readout is expected within 12 months.

Diamyd Medical, a pioneering company in the field of precision medicine, is making significant strides in its mission to prevent and cure Type 1 Diabetes. The company's investigational therapy, Diamyd®, is designed to target specific genetic markers associated with the disease, offering a durable and safe treatment option.

In a recent investor interview, Diamyd Medical's CEO, Ulf Hannelius, and Board Member, Professor Mark Atkinson, highlighted the company's strong safety profile and genetically targeted approach with Diamyd®. The therapy aims to preserve endogenous insulin production by reprogramming the immune system, addressing the root cause of the disease rather than just managing blood glucose levels. Professor Atkinson noted that Diamyd® has one of the strongest safety profiles of any drug seeking to prevent Type 1 Diabetes, making it an attractive treatment option.

Diamyd Medical is expanding its reach by targeting the adult-onset autoimmune diabetes (LADA) segment, which is increasingly recognized as part of the Type 1 Diabetes spectrum. This expansion could more than double the potential market for the company. The company's precision medicine platform is built around matching therapy to the patient's genetic profile, with the goal of reaching a broader patient population. Currently, the company is enrolling only patients with the appropriate HLA genotype in its Phase 3 trial, DIAGNODE-3.

The company's pipeline spans the full disease continuum, from at-risk individuals to slow-progressing adult-onset cases. Increasing scientific consensus now recognizes LADA as a form of Type 1 Diabetes. Diamyd Medical is one of the very few companies to have conducted interventional trials in LADA patients, with safety data extending up to age 70.

Diamyd Medical expects several key milestones within the next 12 months, including top-line results from its single pivotal Phase 3 trial DIAGNODE-3 to support an accelerated approval pathway in the U.S. and GMP certification of its biologics manufacturing facility in Sweden. The company has conducted market research in the United States that supports peak sales potential of USD 2 billion in the Stage 3 Type 1 Diabetes population targeted as the initial indication. Extending the label to adult-onset Type 1 Diabetes could more than double the commercial opportunity.

Diamyd Medical's approach offers a strong case for impact and market adoption. The company sees strong commercial potential, with positive feedback from providers and payers in the U.S. market. The company's mission is not just an investment opportunity but also a chance to improve lives, prevent disease, and contribute to societal benefit.

References:
[1] https://www.prnewswire.com/news-releases/diamyd-medical-highlights-opportunity-in-type-1-diabetes-prevention-adult-onset-market-and-upcoming-phase-3-readout-302433253.html
[2] https://www.prnewswire.com/news-releases/diamyd-medical-highlights-opportunity-in-type-1-diabetes-prevention-adult-onset-market-and-upcoming-phase-3-readout-302433254.html