Diamyd Medical hits a recruitment milestone in DIAGNODE-3 Phase 3 trial

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November 21, 2024 8:09 AM EST

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STOCKHOLM, Nov. 21, 2024 /PRNewswire/ -- 180 patients have now been recruited in the precision medicine Phase 3 trial DIAGNODE-3, exceeding the recruitment target set for the planned early readout in March 2026. The readout is designed to support a potential accelerated Biologics License Application (BLA).

"We are proud to have reached the 180-patient milestone, which is critical for the planned accelerated readout", says Ulf Hannelius, CEO of Diamyd Medical. "This progress reflects the engagement and the strong support from our clinical sites and the Type 1 Diabetes community in advancing innovative, precision-based therapies. With Fast Track designation, orphan drug designation and alignment with the FDA on the accelerated approval pathway, Diamyd Medical remains committed to transforming Type 1 Diabetes care through precision medicine."

180 enrolled patients ensures that at least 170 evaluable patients will be included in the planned early readout. This earlier readout is expected around March 2026 and is designed to provide the foundation for a potential BLA submission under the FDA's accelerated approval pathway. Recruitment efforts for the DIAGNODE-3 trial will continue to ensure comprehensive data collection from the full trial cohort of approximately 330 patients that will be followed for a total of 24 months.

DIAGNODE-3 evaluates Diamyd^®, an antigen-specific immunotherapy targeting a genetic subgroup of individuals with newly diagnosed Stage 3 Type 1 Diabetes. The trial builds on extensive clinical data demonstrating the potential of Diamyd^® to preserve beta cell function in individuals with Type 1 Diabetes, particularly within the genetic subgroup carrying the HLA DR3-DQ2 haplotype. DIAGNODE-3 is designed to assess the preservation of endogenous insulin production as measured by C-peptide as well as glycemic control measured as HbA1c. Diamyd^® was granted Fast Track designation in 2024 for the treatment of Stage 1, 2 and 3 Type 1 Diabetes, and in July this year, C-peptide was acknowledged by the U.S. Food and Drug Administration (FDA) as a reasonably likely surrogate endpoint that can be used to support accelerated approval for Diamyd^®.

About Diamyd Medical

Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that 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 1, 2 and 3 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. Injections into a superficial lymphnode 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 also develops the GABA-based investigational drug Remygen^® as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.