The independent Data Safety Monitoring Board (DSMB) has completed its fifth scheduled safety review of Diamyd Medical's registrational Phase 3 trial, DIAGNODE-3, evaluating the precision medicine immunotherapy Diamyd®. The review identified no safety concerns and resulted in a recommendation to continue the trial as planned.
DIAGNODE-3 is conducted under Fast Track and Orphan Drug Designations granted by the U.S. Food and Drug Administration (FDA), with an agreement in place that an early efficacy readout planned for March 2026 may serve as the basis for a Biologics License Application (BLA) under the FDA's accelerated approval pathway.
"With each successful DSMB review, our confidence grows in Diamyd's potential to address a significant unmet need," says Professor Johnny Ludvigsson, Coordinating Investigator of DIAGNODE-3. "The consistent safety profile demonstrated in DIAGNODE-3 underscores Diamyd's promise as a foundational therapy in Type 1 Diabetes treatment."
"This DSMB recommendation marks another important milestone in our mission to fundamentally transform Type 1 Diabetes care through precision medicine," says Ulf Hannelius, CEO of Diamyd Medical.
The DSMB is an independent committee of clinical experts that monitors safety and efficacy in ongoing studies. This positive review further strengthens the favorable safety profile of Diamyd®. To date, over 220 patients have been enrolled in DIAGNODE-3. Of these, 33 patients have completed the full 24-month follow-up, and 82 have completed their 15-month visit. The dropout rate remains below 0.5%, indicating excellent treatment tolerability. In total, more than 1,000 patients aged 4 to 70 have been treated with Diamyd® in clinical trials, further reinforcing its strong safety database.
About DIAGNODE-3
DIAGNODE-3 (www.diagnode-3.com), is the first precision medicine Phase 3 trial in Type 1 Diabetes. The study evaluates whether Diamyd®, an investigational antigen-specific immunotherapy, aims to preserve endogenous insulin production by reprogramming the immune system and thus modifying the course of the disease in individuals with newly diagnosed Stage 3 Type 1 Diabetes. DIAGNODE-3 is ongoing in the United States and in eight European countries: Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia.
DIAGNODE-3 will enrol up to 330 individuals aged 12 to 29 years, recently diagnosed (within six months) with Type 1 Diabetes, who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for this disease. HLA testing is well-established and widely available to identify such individuals, through a precision-based medicine approach.
This patient population is based on clinical efficacy and safety results from the Phase 2a and Phase 2b trials DIAGNODE-1 and DIAGNODE-2, as well as on the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase 2 and Phase 3trials using Diamyd®. The trial design provides a high probability of reaching its co-primary endpoints of preservation of endogenous insulin-producing capacity measured as stimulated C-peptide and improved blood glucose control as determined by HbA1c.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes. 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. An early read-out of the Phase 3 trial is expected in March 2026. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a largescale meta-analysis as well as in the Company's prospective European Phase IIb trial. 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. 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.
Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com
The information was provided by the contact person above, for publication on April 25, 2025, 14.00 CET.
