Diamyd Medical has announced a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial.
The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications.
“We are extremely pleased with the DSMB’s recommendation to continue the DIAGNODE-3 trial as planned,” says Ulf Hannelius, CEO of Diamyd Medical. “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 U.S. Food and Drug Administration, allowing for an accelerated approval pathway for Diamyd. We look forward to achieving our next milestones towards this goal.”
The interim analysis evaluated six-month data from 74 patients enrolled in the trial, assessing the likelihood of the trial achieving one of its co-primary endpoints, specifically the preservation of endogenous insulin-producing capacity measured as stimulated C-peptide. The DSMB’s recommendation is based on the data observed to date, indicating that the trial is on track and has the potential to meet its objectives.
Photo of Ulf Hannelius: Diamyd/Umeå Biotech Incubator
