Diamyd Medical Secures Key US Patent Protection for Intralymphatic Type 1 Diabetes Immunotherapy Approach
Diamyd Medical Ab, a Sweden-based precision medicine company, has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a critical patent covering the intralymphatic administration of retogatein (rhGAD65) with alum for type 1 diabetes prevention and treatment.
The retogatein patent represents a strategic milestone for the company's antigen-specific immunotherapy platform, with corresponding patent rights already secured in multiple international jurisdictions including Europe, Australia, Hong Kong, China, Canada, South Africa, Japan, Russia, and Israel. The newly allowed US patent is anticipated to expire in 2035, providing substantial intellectual property protection for Diamyd's innovative therapeutic approach.
Retogatein Patent: Targeting Immune Tolerance
The patent specifically covers an intralymphatic administration method designed to induce antigen-specific immune tolerance in patients carrying the HLA DR3-DQ2 genetic profile. This approach targets approximately 40% of type 1 diabetes patients in Europe and the United States, representing a precisely defined patient population with significant unmet medical needs.
The protected technology involves administering retogatein, a recombinant GAD65 protein, through an intralymphatic route combined with alum adjuvant. This method aims to preserve endogenous insulin production by modulating the immune response in recently diagnosed type 1 diabetes patients.
Clinical Development and Regulatory Landscape
Diamyd Medical is currently conducting the DIAGNODE-3 confirmatory Phase 3 trial, which will evaluate retogatein's efficacy across multiple patient age groups, including children, adolescents, and adults with newly diagnosed Stage 3 type 1 diabetes. The company anticipates an FDA-aligned interim efficacy readout by the end of March 2026.
The retogatein patent comes with additional regulatory advantages. As a biological product, the therapy is eligible for market exclusivity in the United States and Europe, independent of patent protection, contingent upon regulatory approval. The asset has already received Orphan Drug Designation and Fast Track Designation from the US FDA for treating Stage 3 type 1 diabetes, with similar designations for Stage 1 and 2 pre-symptomatic conditions.