STOCKHOLM, March 4, 2021 / PRNewswire / –
The upcoming phase III study with Diamyd® in emerging type 1 diabetes is based on the first precision medicine approach in this area. The study aims to confirm the effectiveness and safety of Diamyd® in people who have recently been diagnosed with type 1 diabetes and who have the HLA DR3-DQ2 genetic haplotype.
The Phase III study will enroll around 330 people aged 12 to 28 who have recently been diagnosed with type 1 diabetes and who have the HLA DR3-DQ2 haplotype. This patient population is based on the clinical efficacy and safety results from the Phase IIa and Phase IIb DIAGNODE-1 and DIAGNODE-2 studies, as well as the large-scale meta-analysis that includes data from more than 600 people from previous Phase II and Phase III Trials with Diamyd®. Another stratification for HLA haplotypes is included to assess the potential super responder group of individuals positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.
“We are breaking new ground and are delighted to be driving the first precision medicine approach for type 1 diabetes with this comprehensive data package,” he said Ulf Hannelius, CEO of Diamyd Medical. “We have considered valuable input on study design and efficacy endpoints provided by regulators, payers and diabetes experts to optimize the likelihood of a successful Phase III trial. We look forward to engaging with you the regulatory authorities throughout the central Phase III program, we will start the study in 2021 and, with the support of a partner and institutional investors, secure the further necessary operational and strategic resources to maximize the potential of Diamyd. “
Co-primary endpoints, consisting of change in endogenous insulin production and long-term blood sugar (measured as stimulated C-peptide or HbA1c), measured 24 months after the start of the study, are used to support the biological and clinical relevance of the treatment. This is in line with guidelines from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as a health technology assessment panel hosted by Diamyd Medical.
The phase III study is being carried out at approximately 50 clinical sites in Europe and The United States. After a running-in period in which all subjects receive vitamin D for one month, the subjects are randomized 2: 1 to receive three intralymphatic injections of Diamyd® or a suitable placebo every month. The primary effectiveness is read 24 months after the start of the study. The design offers a high probability of meeting its co-primary endpoints for maintenance of the stimulated C-peptide and lower HbA1c based on efficacy data from previous studies with the HLA-restricted patient population.
In parallel to the Phase III study, accelerated approval routes will be assessed based on the comprehensive data package to support clinical efficacy and safety in individuals with the HLA DR3-DQ2 haplotype.
About Diamyd Medical
Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd® is an antigen-specific immunotherapy to maintain endogenous insulin production. Significant results were shown in a genetically predefined group of patients in a large-scale meta-analysis, as well as in the company’s European Phase IIb study DIAGNODE-2, in which the diabetes vaccine was administered directly into a lymph node in children and young adults with the recently diagnosed type -1 diabetes. A new plant for the production of vaccines for the production of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd®, is being set up in Umeå. Diamyd Medical is also developing the GABA-based test preparation Remygen® as a therapy to regenerate endogenous insulin production and to improve the hormonal response to hypoglycemia. A Remygen® study initiated by researchers in patients who have had type 1 diabetes for more than five years is currently ongoing Uppsala University Hospital. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB.
Diamyd Medical’s B share is traded on the Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the company’s certified consultant. Phone: +46 8-528 00 399, email: firstname.lastname@example.org
For further information please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
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SOURCE Diamyd Medical AB