Diamyd Medical

Precision Medicine from the Nordics -
 A Deep Dive into Diamyd Medical

The Nordic life science sector continues to gain global recognition as a hub for deep science, innovation, and international collaboration. Supported by strong academic research and a highly educated workforce, Sweden’s life science industry represents nearly 10% of the country’s total product exports. Nordic companies often combine early scientific discovery with a global outlook from the start, creating a natural bridge between European innovation and the U.S. market.

In this SACC San Francisco & Silicon Valley member deep dive, we turn to Diamyd Medical and its board member Dr. Karin Rosen, MD., Ph.D, a Silicon Valley based physician-scientist with more than 20 years of global biotech senior executive leadership experience developing and launching numerous biotech products in the US. With a background spanning clinical development, regulatory engagement, and medical affairs across major biopharma companies, Karin brings both scientific depth and strategic perspective to the company’s current momentum.

Diamyd Medical is currently in Phase 3 clinical development in the United States and Europe, advancing an antigen-specific immunotherapy for autoimmune type 1 diabetes. The treatment is designed to preserve the body’s own insulin production by addressing the underlying immune response, not by broadly suppressing it. As Karin puts it, “If we can help patients preserve even part of their own insulin production, that can mean better glucose control, fewer complications over time, and a fundamentally different outlook on living with type 1 diabetes. That is what disease-modifying treatment is about.”

The scientific foundation behind this approach aligns with recent Nobel Prize–recognized discoveries in peripheral immune tolerance and regulatory T-cells, a breakthrough that deepen the understanding of how the immune system can be guided not to attack the body’s own tissues. For Diamyd Medical, this is not abstract science, it is the core mechanism behind its therapy.

What makes this moment particularly significant is the progress Diamyd Medical has made with U.S. regulators around its study drug, which is still under development in a Phase 3 clinical trial. The U.S. Food and Drug Administration (FDA) has provided written feedback allowing the company to analyze its main results nine months earlier than planned, an important development following ongoing dialogue with the FDA regarding the clinical trials’s design.

The trial focuses on patients with a specific genetic profile and measures C-peptide, a marker of how much insulin the body naturally produces. When the pancreas makes insulin, it releases C-peptide at the same time, making it a reliable way to track remaining insulin production. Diamyd Medical is looking to see whether patients receiving the therapy preserve more of their own insulin compared to those who do not. If C-peptide levels stay higher in the treated group, it suggests the therapy may be helping protect the insulin-producing cells.

For Karin, this scientific rigor is inseparable from strategic foresight. Advancing a study drug through late-stage development requires not only strong data, but early and thoughtful alignment with regulators and market stakeholders. “You need to have a clear plan for the U.S. market,” she notes. “As Nordic companies, we are used to building our programs with scientific rigor from the start, with clear endpoints and early regulatory dialogue.”

Karin emphasizes that longer-term thinking around market access must be an integrated part of the drug development strategy. This includes ensuring that patients can access newly approved treatments not only through regulatory approval but also through payer coverage and reimbursement. Taking this comprehensive approach is especially important when entering a market as complex and significant as the United States, which can potentially account for 80–90% of total revenue.

Diamyd Medical reflects the strengths of the Nordic ecosystem: scientific depth, disciplined execution, and global ambition. As a valued member of SACC San Francisco & Silicon Valley, the company exemplifies how Nordic innovation could translate into meaningful clinical progress on the international stage. We look forward to following Diamyd Medicals’s next milestones and continuing to spotlight members driving precision medicine forward.