Diamyd Medical Secures Key US Patent for Type 1 Diabetes Immunotherapy
Diamyd Medical announced today, February 9, 2026, that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent covering a crucial aspect of its retogatein (rhGAD65) therapy for type 1 diabetes. This patent protects the intralymphatic administration of retogatein with alum, a method used in the ongoing Phase 3 clinical trial.
Expanding Global Patent Protection
This U.S. Patent builds upon Diamyd Medical’s existing intellectual property portfolio, with similar rights already established in Europe, Australia, Hong Kong, China, Canada, South Africa, Japan, Russia, and Israel. The anticipated expiration date of the U.S. Patent is 2035, providing substantial long-term protection for the company’s innovation.
Retogatein: A Precision Medicine Approach
Retogatein is an investigational antigen-specific immunotherapy designed to induce immune tolerance to GAD65, a protein involved in the autoimmune attack on insulin-producing cells in type 1 diabetes. The therapy aims to preserve the body’s ability to produce its own insulin. It is specifically targeted towards individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene, representing a significant portion of the patient population in Europe and the US.
Phase 3 Trial and Upcoming Data
The intralymphatic administration method covered by the new patent is currently being utilized in the Phase 3 DIAGNODE-3 trial. This trial is evaluating retogatein in children, adolescents, and adults recently diagnosed with Stage 3 type 1 diabetes. An interim efficacy readout, aligned with FDA requirements, is expected by the end of March 2026.
Regulatory Exclusivity Potential
Beyond patent protection, retogatein, as a biological product, is eligible for regulatory market exclusivity in both the United States and Europe, pending regulatory approval. This additional layer of protection could extend the period of market exclusivity beyond the patent life.
What is Intralymphatic Administration?
Intralymphatic administration involves delivering the drug directly into the lymphatic system. This method can enhance the immune response and potentially improve the efficacy of immunotherapies like retogatein. It’s a targeted approach designed to maximize the drug’s impact on the immune system.
The Future of Type 1 Diabetes Treatment
The development of antigen-specific immunotherapies like retogatein represents a significant shift in the treatment of type 1 diabetes. Traditionally, treatment has focused on managing blood sugar levels with insulin. However, therapies aimed at modifying the underlying autoimmune process offer the potential for long-term disease modification and even prevention.
The Role of Personalized Medicine
Diamyd Medical’s focus on the HLA DR3-DQ2 genotype highlights the growing importance of personalized medicine in diabetes treatment. Identifying patients who are most likely to respond to a particular therapy can significantly improve treatment outcomes and reduce healthcare costs.
Beyond Retogatein: The Pipeline of Immunotherapies
Retogatein is not the only immunotherapy being investigated for type 1 diabetes. Several other approaches are in development, including therapies targeting different autoantigens and utilizing different immune modulation strategies. This expanding pipeline suggests a promising future for immunotherapies in the fight against type 1 diabetes.
Frequently Asked Questions
What is retogatein?
Retogatein (rhGAD65) is an investigational antigen-specific immunotherapy for type 1 diabetes.
What does the patent cover?
The patent covers the intralymphatic administration of retogatein with alum.
What is the DIAGNODE-3 trial?
It’s a Phase 3 clinical trial evaluating retogatein in patients with newly diagnosed Stage 3 type 1 diabetes.
When is the interim efficacy readout expected?
The readout is expected by the end of March 2026.
What is regulatory market exclusivity?
It’s a period of exclusive marketing rights granted to a drug by regulatory authorities, independent of patent protection.
What is the significance of the HLA DR3-DQ2 gene?
Retogatein is designed for patients carrying this gene, which constitutes approximately 40% of those with type 1 diabetes in Europe and the US.
