According to Cision PRS Newswire, Diamyd Medical, the makers of Diamyd, a precision medicine and antigen-specific immunotherapy, announced today that the FDA has partially lifted its clinical hold on the confirmatory Phase III trial DIAGNODE-3, which is testing Diamyd Safety And efficacy in people with newly diagnosed type 1 diabetes.
The Food and Drug Administration has authorized the introduction of the DIAGNODE-3 in the United States. Ulf Hannelius, CEO of Diamyd Medical, termed this a “major milestone” for the company and, more importantly, for people with Type 1 diabetes.
He mentioned, “We are excited to bring DIAGNODE-3 to the United States, and we look forward to working with researchers and patient advocacy groups to ensure that everybody with type 1 diabetes who might benefit from our medicine has access to it.”
The crucial DIAGNODE-3 research will begin in the United States in September 2022 due to a clinical hold imposed by the Food and Drug Administration. Since then, several contacts with the FDA have taken place to resolve the agency’s concerns.
Diamyd Medical will commence discussions with IRBs and clinical sites in the United States as soon as possible to begin recruiting for the study. DIAGNODE-3 patient recruitment has been approved in eight European countries.
The DIAGNODE-3 Phase III study will enroll about 330 patients aged 12 to 28 with type 1 diabetes who have the HLA DR3-DQ2 haplotype. The selection of this patient group is explained by clinical effectiveness and safety findings from the DIAGNODE-1 and DIAGNODE-2 Phase IIa and Phase IIb studies, as well as a large-scale meta-analysis of data from over 600 individuals in past Phase II and Phase III trials using Diamyd®.
If a potential super responder test positive for HLA DR3-DQ2 but negative for HLA DR4-DQ8, they will be further categorized for HLA haplotypes.
Phase III research will involve more than fifty different medical facilities. The critical effectiveness readout will occur 24 months after baseline, with individuals receiving vitamin D for one month as a “run-in” before getting three intralymphatic injections of Diamyd or a matched placebo, one month apart.
Previous trial efficacy data in the HLA-restricted patient population indicate a high likelihood of success for the design’s primary endpoints of 1) maintaining the body’s ability to produce its insulin (as measured by stimulated C-peptide) and 2) reducing the time that blood glucose levels remain above a target (as measured by HbA1c).
Diamyd Medical creates precision medicine-based treatments for Type 1 diabetic patients. Diamyd® is an antigen-specific immunotherapy that can help you maintain your insulin production. The DIAGNODE-3 confirmatory Phase III study is now enrolling participants from eight European countries with newly diagnosed Type 1 Diabetes.
When Diamyd® was injected directly into a lymph node in adolescents and young adults with newly diagnosed type 1 diabetes in the Company’s European Phase IIb research DIAGNODE-2, positive results were found in a broad genetically predetermined patient population.
