Diamyd Medical Reports Positive Interim Phase 3 Results for Type 1 Diabetes

STOCKHOLM, July 30, 2024, Diamyd Medical has announced a successful interim analysis for its ongoing Phase 3 DIAGNODE-3 trial. This analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), led to a favorable recommendation to proceed with the trial without any modifications.

"We are extremely pleased with the DSMB's recommendation to continue the DIAGNODE-3 trial as planned," stated Ulf Hannelius, CEO of Diamyd Medical. "This positive outcome reaffirms our confidence in the potential for Diamyd® to address an unmet medical need in Type 1 Diabetes. We are committed to advancing this promising therapy as part of a process recently approved by the U.S. Food and Drug Administration, allowing for an accelerated approval pathway for Diamyd®. We look forward to achieving our next milestones towards this goal."

The interim analysis evaluated six-month data from 74 patients enrolled in the trial, assessing the likelihood of the trial achieving one of its co-primary endpoints, specifically the preservation of endogenous insulin-producing capacity measured as stimulated C-peptide. The DSMB's recommendation is based on the data observed to date, indicating that the trial is on track and has the potential to meet its objectives.

The DIAGNODE-3 trial is designed to confirm the safety and efficacy of the antigen-specific immunotherapy Diamyd® in individuals diagnosed with Type 1 Diabetes. The trial is being conducted in the United States and eight European countries, including Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary, and Estonia. Up to 330 participants aged 12 to 29 years, who have been recently diagnosed (within six months) with Type 1 Diabetes and carry the HLA DR3-DQ2 haplotype, are being enrolled. The trial also includes further stratification for HLA haplotypes to identify a potential superresponder group.

The selection of this patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as a large-scale meta-analysis of data from over 600 individuals from previous Phase II and Phase III trials using Diamyd®. The trial aims to preserve endogenous insulin production, measured as stimulated C-peptide, and improve blood glucose control, determined by HbA1c levels.

Diamyd Medical is also considering the possibility of an earlier readout in the DIAGNODE-3 trial. The FDA has acknowledged that C-peptide could be used as a surrogate endpoint that is reasonably likely to predict the clinical benefit of preserving endogenous insulin production. Accelerated Approval could be sought based on demonstrating significant treatment-related benefits on C-peptide levels in response to Diamyd® administration.

The DIAGNODE-3 trial is partially funded by Breakthrough T1D, the leading global Type 1 Diabetes research and advocacy organization.

Diamyd Medical specializes in developing 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 designed to preserve endogenous insulin production. It has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA for treating Stage 1, 2, and 3 Type 1 Diabetes. The DIAGNODE-3 trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes across eight European countries and the US.

Significant results have previously been demonstrated in a large genetically predefined patient group, shown in a large-scale meta-analysis and the European Phase IIb trial. In these studies, Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes, optimizing the treatment response. 

A biomanufacturing facility is being developed in Umeå, Sweden, to produce the recombinant GAD65 protein, the active ingredient in Diamyd®. Additionally, Diamyd Medical is developing the GABA-based investigational drug Remygen® for treating metabolic diseases. They are also major shareholders in NextCell Pharma AB, a stem cell company, and MainlyAI AB, an artificial intelligence company.

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