Diamyd Medical has signed a partnership agreement with a centre of excellence, DiaUnion, to recruit study subjects in a type 1 diabetes (T1D) prevention trial of Diamyd (GAD-alum).
Named DiaPrecise, the open-label trial will analyse the feasibility, immune response, and safety of intralymphatic injections of Diamyd in children with the HLA DR3-DQ2 genotype and who are at risk of developing T1D.
Clinical parameters, such as the production of endogenous insulin and blood glucose control offered by the treatment, will also be analysed.
In the trial, Diamyd will be administered directly into a lymph node in ten 16 children aged eight to 18 years old.
The trial is currently underway at the Department of Clinical Sciences at Lund University, Malmö, Sweden.
It is being carried out under the ASSET programme, with funding from the Swedish Innovation Agency VINNOVA.
An antigen-specific immunotherapy, Diamyd is intended to preserve the production of endogenous insulin.
The company is establishing a biomanufacturing site in Umeå to produce an active ingredient of Diamyd, recombinant GAD65.
Diamyd Medical president and CEO Ulf Hannelius said: “We are thrilled to partner with DiaUnion around the precision medicine trial DiaPrecise.
“An infrastructure for screening of T1D is a prerequisite to evaluate preventive treatments, and this partnership is important to advance our goal of delaying or preventing the progression of T1D, with the antigen-specific immunotherapy Diamyd.”
