The special protocol assessment (SPA) enables DeCode to proceed with the recruitment of participants for the phase III trial. The SPA is an agreement between the FDA and DeCode on the objectives, design, primary endpoints and statistical analysis plan for the trial.
Achievement of the pre-specified endpoints would fulfill requirements to support regulatory approval for a new drug application for DG031.
“We are very pleased to have an SPA for the phase III clinical trial of DG031, and are on track to enroll our first patients within the coming weeks. The design of this trial represents a powerful use of human genetics in the drug development process, which enhances the likelihood of success,” said Kari Stefansson, CEO of DeCode.