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.
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.
The company will now immediately start interacting with the clinical sites and institutional review boards to include the US clinical sites in the trial.
The 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.