Type 1 Diabetes prevention trial with the antigen-specific immunotherapy Diamyd® approved to start

The Swedish Medical Products Agency and the Ethical Review Authority have approved the start of DiaPrecise, an open-label prevention trial with the antigen-specific immunotherapy Diamyd®. The trial will evaluate the safety, feasibility and immune response of intralymphatic injections of Diamyd® in children at risk of Type 1 Diabetes, who also carry the genetically defined haplotype HLA DR3-DQ2. DiaPrecise is part of the ASSET program (AI for the Sustainable Prevention of Autoimmunity in Society), coordinated by Diamyd Medical and funded by Sweden’s Innovation Agency VINNOVA.

“Preventing or delaying the time to clinical diagnosis of Type 1 Diabetes in at-risk children is of greatest importance and a perfect application for the beta cell-preserving precision medicine immunotherapy Diamyd that has a benign safety profile and low treatment burden”, says Ulf Hannelius, CEO of Diamyd Medical.

“Screening healthy children for autoantibody biomarkers easily detects children at risk for Type 1 Diabetes”, says Åke Lernmark, Professor at Lund University and member of Diamyd Medical’s Scientific Advisory Board. “A treatment that halts the disease progression is of global interest. The DiaPrecise trial is precision medicine with antigen-specific immunotherapy. Diamyd, containing GAD, may induce immunological tolerance and stop disease in those children whose immune system disproportionally reacts to GAD. Screening followed by Diamyd immunotherapy is a hallmark of the ASSET program to use precision medicine for diabetes prevention.”

“We hope that being able to intervene at an early stage of the disease process will further improve the effects of Diamyd on Type 1 Diabetes”, says Markus Lundgren, consultant pediatrician at Lund University and Principal Investigator for DiaPrecise. “Using antigen-specific immune tolerance would be a safe and accessible path towards stopping Type 1 Diabetes”.

About DiaPrecise – Precision Prevention of Type 1 Diabetes
DiaPrecise is an open-label clinical trial where Diamyd® (GAD-alum) is given directly into a lymph node in 10 to 16 children aged 8 to 18 years who are at high risk of being diagnosed with clinical Type 1 Diabetes (so called Stage 1 or Stage 2 Type 1 Diabetes, see below), and who also carry the genetically defined haplotype HLA DR3-DQ2, associated with clinical response to Diamyd®. The aim of the trial is to evaluate the safety and feasibility of two or three intralymphatic injections with Diamyd® as well as the effect on the immune system and clinical parameters including endogenous insulin production and blood glucose control. The Principal Investigator of DiaPrecise is Dr. Markus Lundgren, Researcher at the Department of Clinical Sciences at Lund University and consultant pediatrician at Kristianstad hospital, Sweden. Sponsor of the trial is Diamyd Medical.

DiaPrecise is the first precision prevention trial with Diamyd®, and is part of the ASSET program (AI for the Sustainable Prevention of Autoimmunity in Society) coordinated by Diamyd Medical. ASSET is funded by the Swedish Innovation Agency VINNOVA. For more information on ASSET, please visit www.asset.healthcare.

Staging of Type 1 Diabetes – Opportunity for Prevention and Early Intervention
Type 1 Diabetes (T1D) is a chronic autoimmune disease that attacks the insulin producing beta cells in the pancreas. The onset of T1D starts months to years before symptomatic disease and is divided into disease stages. Individuals with Stage 1 T1D have tested positive for two or more diabetes-related autoantibodies but still have normal blood glucose values and no symptoms of the disease. Individuals with Stage 2 T1D have progressed to abnormal blood glucose values (so-called dysglycemia) but are otherwise asymptomatic. Stage 3 T1D is synonymous with clinically diagnosed T1D. The target population for the DiaPrecise trial comprises individuals with Stages 1 T1D or Stage 2 T1D, whilst individuals with Stage 3 T1D (i.e. clinically diagnosed T1D) are the target population for the ongoing pivotal Phase III trial DIAGNODE-3 with the antigen-specific immunotherapy Diamyd®.

About Diamyd Medical
Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. DIAGNODE-3, a confirmatory Phase III trial is actively recruting pateients with recent-onset Type 1 Diabetes in eight European countries. 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 European Phase IIb trial DIAGNODE-2, where the Diamyd® was administered directly into a lymph node in children and young adults with recently diagnosed Type 1 Diabetes. A manufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen® trial in individuals living with Type 1 Diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB as well as 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
info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com

The information was provided by the contact person above, for publication on December 16, 2022, 14.20 CET.


  PDF version