The US Food and Drug Administration (FDA) has lifted the partial clinical hold on the Phase III DIAGNODE-3 trial of Diamyd Medical’s antigen-specific immunotherapy Diamyd.
The Phase III trial has been designed to assess Diamyd’s safety and efficacy in patients who are recently diagnosed with type 1 diabetes.
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It has been approved to commence in the US after receiving the FDA’s decision.
In September last year, the regulator issued a partial clinical hold on the pivotal trial.
Since then, many interactions have been held with the FDA for resolving queries raised by the agency.
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The company will now immediately start interacting with the clinical sites and institutional review boards to include the US clinical sites in the trial.
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By GlobalDataThe Phase III DIAGNODE-3 trial already received approval and is currently recruiting participants in eight European countries.
Nearly 330 people aged 12 years to 28 years, who are recently diagnosed with type 1 diabetes and people carrying the HLA DR3-DQ2 haplotype, will be enrolled in the trial to be conducted at over 50 clinical sites.
Diamyd Medical CEO Ulf Hannelius said: “This is a significant milestone for Diamyd Medical and more importantly, for patients diagnosed with type 1 diabetes.
“We are looking forward to moving ahead with DIAGNODE-3 in the US and we will work diligently with investigators and patient groups to make sure that our therapy can be made available to type 1 diabetes patients in need.”
All participants in the trial will initially receive vitamin D for one month. Later, they will be randomised in a 2:1 ratio to receive three Diamyd intralymphatic injections, or a matching placebo, one month apart.
