Diamyd Medical has reported that its Phase III DIAGNODE-3 clinical trial of antigen-specific immunotherapy, Diamyd, in Type 1 Diabetes (T1D) patients reached recruitment milestone enrolling 100 patients.
DIAGNODE-3 is currently active in the US and eight European countries namely the Czech Republic, Netherlands, Spain, Sweden, Germany, Poland, Hungary and Estonia.
The trial is assessing the efficacy and safety of the immunotherapy in preserving endogenous insulin production in individuals with T1D.
It is designed to include up to 330 individuals of the age 12 to 29 years, who have been diagnosed with T1Dwithin the last six months.
These participants should also carry the HLA DR3-DQ2 haplotype, which is a genetic marker associated with a higher risk for the disease, to be part of the trial.
The inclusion criteria for DIAGNODE-3 are informed by the outcomes from prior Phase IIa and Phase IIb clinical trials, DIAGNODE-1 and DIAGNODE-2, as well as meta-analysis data from over 600 people from prior Phase II and Phase III studies of Diamyd.
An additional layer of stratification is being applied in DIAGNODE-3 to identify a potential 'super responder' group. This subgroup consists of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8, which may indicate a greater likelihood of responding favourably to the treatment.
So far, the DIAGNODE-3 trial has reported no serious adverse events, and all enrolled patients have continued their participation.
The trial's design is structured to maximise the chances of meeting its co-primary endpoints, which are the preservation of the body's own insulin production, as measured by stimulated C-peptide, and the improvement of blood glucose control, determined by HbA1c levels.
Diamyd received orphan drug and fast track designations from the US Food and Drug Administration (FDA).
Diamyd Medical president and CEO Ulf Hannelius said: “This is an important milestone in our Phase III trial and the notable zero dropout rate confirms our insights from previous trials regarding the safety and convinience of the treatment.
“We are deeply grateful to our participants for their continued commitment to the trial and to the dedicated staff at our participating clinics for their relentless efforts.”
In November 2022, the US FDA lifted the partial clinical hold on the company’s Phase III DIAGNODE-3 trial of Diamyd.
