Diamyd Medical announces expanded financial support from Breakthrough T1D

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February 12, 2025 5:06 AM EST

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STOCKHOLM, Feb. 12, 2025 /PRNewswire/ -- Diamyd Medical will receive USD 1.75 million in expanded collaboration support from Breakthrough T1D (formerly JDRF), the world's leading Type 1 Diabetes research and advocacy organization, in support of the DIAGNODE-3 Phase 3 trial to facilitate the potential submission of a regulatory filing for approval.

This additional funding builds upon the existing collaboration to support the ongoing DIAGNODE-3 trial evaluating a precision medicine antigen-specific immunotherapy for autoimmune diabetes. The funding is provided through Breakthrough T1D's Industry Discovery & Development Partnerships (IDDP) Program, which focuses on advancing the commercialization of innovative therapeutics and devices for the treatment, prevention, and cure of Type 1 Diabetes and its complications.

"We are thrilled to strengthen our collaboration with Breakthrough T1D as we work towards bringing our antigen-specific immunotherapy to market," says Ulf Hannelius, CEO of Diamyd Medical. "This additional funding is a testament to the potential of our approach in accelerating patient recruitment and preparations ahead of a potential accelerated approval."

"At Breakthrough T1D, we are dedicated to pushing forward transformative therapies that can change the course of type 1 diabetes," says Joshua Vieth, Ph.D., Senior Director, Research at Breakthrough T1D. "We are excited to build on our collaboration with Diamyd Medical's Phase 3 trial to support ongoing efforts and the potential impact to the type 1 diabetes community."

About Diamyd Medical

Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying a HLA DR3-DQ2 gene. Diamyd^® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) Type 1 Diabetes. Diamyd^®has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd^® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40% of patients with Type 1 Diabetes in Europe and the US. Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd^®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.