STOCKHOLM, July 18, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd^® (rhGAD65/alum) to treat Type 1 Diabetes in pediatric patients with Stage 1 or Stage 2 Type 1 Diabetes carrying the genotype HLA DR3-DQ2. Earlier this year, Diamyd^® received Fast Track designation for the treatment of individuals with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.

"We are thrilled to receive our second Fast Track designation for Diamyd, this time for its potential to delay the onset of clinically diagnosed type 1 diabetes", says Ulf Hannelius, CEO of Diamyd Medical. "This recognition once again underscores the potential of our precision medicine approach and the urgent need for new treatment options for type 1 diabetes across the disease spectrum. We now have the opportunity to work closely with the FDA to accelerate the development of Diamyd also as a preventive medicine."

For further information regarding Fast Track drug development programs, please refer to the Guidance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

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 Type 1 Diabetes.

Diamyd Medical develops treatments for all stages of 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 pivotal Phase III trial DIAGNODE-3 with the antigen-specific immunotherapy 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 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.

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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