Diamyd Medical has announced that the independent Data Safety Monitoring Board (DSMB) recommended the continuation of the Phase III DIAGNODE-3 trial of Diamyd for type 1 diabetes (T1D) without modifications.
The recommendation comes after the company reported positive interim analysis data from the Phase III trial.
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Interim analysis findings included data from 74 patients over six months, focusing on the trial’s likelihood of preserving endogenous insulin production.
The trial is evaluating the safety and efficacy of the antigen-specific immunotherapy Diamyd in T1D patients.
It enrolled participants in the US and eight European countries, including the Czech Republic, Estonia, Germany, Hungary, the Netherlands, Poland, Spain, and Sweden.
It enrolled individuals aged 12 to 29 years old, who were recently diagnosed with T1D and carry the HLA DR3-DQ2 haplotype, a genetic marker associated with the disease.
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By GlobalDataIn April this year, the company reported that the DIAGNODE-3 trial reached its recruitment milestone, enrolling 100 patients.
The patient selection is based on positive results from earlier Phase IIa and IIb trials, DIAGNODE-1 and DIAGNODE-2, as well as data from over 600 individuals from previous trials.
The co-primary endpoints of the DIAGNODE-3 trial include the preservation of the body’s insulin-producing capacity and improved blood glucose control.
Diamyd Medical CEO Ulf Hannelius said: “We are extremely pleased with the DSMB’s recommendation to continue the DIAGNODE-3 trial as planned.
“This positive outcome reaffirms our confidence in the potential for Diamyd to address an unmet medical need in type 1 diabetes. We are committed to advancing this promising therapy as part of a process recently approved by the US Food and Drug Administration, allowing for an accelerated approval pathway for Diamyd.”
The company is also considering an earlier readout for the DIAGNODE-3 trial, following the FDA’s acknowledgement that the C-peptide could serve as a surrogate endpoint.
This could lead to accelerated approval if significant treatment-related benefits on C-peptide levels are demonstrated following Diamyd administration.
