#USA #Stockholm #Type 1 Diabetes #Diamyd Medical #retogatein

Diamyd Medical Secures Key U.S. Patent Allowance for Retogatein

Diamyd Medical, a pioneer in innovative therapies for type 1 diabetes, recently announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a pivotal patent pertaining to the use of retogatein (rhGAD65) administered alongside alum. This method is designed for the prevention and treatment of type 1 diabetes, marking a significant step for Diamyd Medical in advancing its antigen-specific immunotherapy platform.

A Significant Milestone

The newly allowed U.S. patent application adds to an extensive international portfolio that includes corresponding rights already established in various regions such as Europe, Australia, Hong Kong, China, Canada, South Africa, Japan, Russia, and Israel. Once issued, this patent is set to enhance Diamyd Medical’s intellectual property protection significantly until at least 2035, thus fortifying their position in the competitive biotech market.

Ulf Hannelius, the President and CEO of Diamyd Medical, articulated the importance of this patent allowance, stating, "This Notice of Allowance further strengthens our global intellectual property for our precision medicine and antigen-specific immunotherapy in type 1 diabetes. Securing patent protection in the U.S. is a key milestone as retogatein advances toward potential commercialization."

Clinical Trials and Future Applications

The method protected by the patent is currently under investigation in the Phase 3 DIAGNODE-3 trial. This pivotal study involves children, adolescents, and adults diagnosed with Stage 3 type 1 diabetes. An interim efficacy readout from this trial, which aligns with FDA guidelines, is anticipated by the end of March 2026. This readout is essential, as it may lead to critical insights into the efficacy of retogatein in preserving insulin production and further enhancing the treatment options available for type 1 diabetes patients.

Retogatein's Role in Diabetes Management

Retogatein is classified as a biological product and uniquely qualifies for regulatory market exclusivity in the U.S. and Europe, separate from patent protection. This feature sets a strong foundation for Diamyd Medical as it develops and aims to commercialize retogatein for patients with type 1 diabetes who have the HLA DR3-DQ2 genotype. The Company’s research has shown promising outcomes in preserving endogenous insulin production in this genetically defined patient group, which constitutes a substantial portion of type 1 diabetes cases in Europe and the U.S.

Future Developments and Infrastructure

Diamyd Medical is currently in the process of establishing a biomanufacturing facility in Umeå, Sweden, which is crucial for the production of retogatein, the active ingredient in their immunotherapy. Furthermore, the Company holds significant shares in NextCell Pharma AB and MainlyAI AB, indicating a broad strategic vision that encompasses advancements in precision medicine and artificial intelligence.

With strong backing from its share price on Nasdaq First North Growth Market and a robust pipeline of clinical trials, Diamyd Medical is well-positioned to lead the market in diabetes advancements. The expected gains from this patent will not only strengthen its operational capabilities but also enhance the range of treatment options available to those battling type 1 diabetes, a condition that affects millions across the globe.

In conclusion, the approval of this patent stands as a testament to Diamyd Medical’s commitment to innovation in the diabetes realm and represents a promising leap forward in the quest for effective treatments that can transform patient outcomes.