STOCKHOLM, July 30, 2024 /PRNewswire/ -- Diamyd Medical today announced a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications.

"We are extremely pleased with the DSMB's recommendation to continue the DIAGNODE-3 trial as planned," says 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.

About DIAGNODE-3
The confirmatory Phase III trial DIAGNODE-3 (www.diagnode-3.com), evaluating the safety and efficacy of the antigen-specific immunotherapy Diamyd^® in individuals diagnosed with Type 1 Diabetes 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 enroll 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. A further stratification for HLA haplotypes is included to evaluate a potential superresponder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8. 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 IIa and Phase IIb 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 II and Phase III trials 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.

As previously announced, Diamyd Medical is evaluating the potential of an earlier readout in the DIAGNODE-3 trial. This is based on the FDA acknowledging that C-peptide could be used by Diamyd Medical as a surrogate endpoint that is reasonably likely to predict the clinical benefit of preservation of endogenous insulin production. As such, Accelerated Approval could be sought based on demonstrating significant treatment-related benefits on C-peptide levels in response to Diamyd^® administration.

DIAGNODE-3 is supported, in part, by funding from Breakthrough T1D (formerly JDRF), the leading global Type 1 Diabetes research and advocacy organization.

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 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.

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.

CONTACT:

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

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