The company said the review points to three main areas: the operational complexity of intralymphatic administration, the potential importance of starting treatment sooner after diagnosis, and the need to carefully assess drug-product potency.

“DIAGNODE-3 did not meet the pre-specified criteria required to continue, and we are acting on that result with scientific discipline and financial responsibility,” says Anders Essen-Möller, Interim CEO of Diamyd Medical.

Diamyd Medical said the review did not identify a single clear cause for the outcome or any new safety concerns, and that retogatein has now been given to more than 1,000 participants across clinical studies.