Vertex Pharmaceuticals paused a Type 1 diabetes drug trial after two patients died. The drugmaker said the deaths are unrelated to the therapy and that it is waiting on independent review before restarting the study.
The trial is a phase 1/2 study for Vertex's VX-880, an insulin-producing therapy being tested among diabetes patients with hypoglycemia, according to a Jan. 7 news release. Seventeen participants were enrolled in the study, according to clinicaltrials.gov, but one patient withdrew consent from the study, the release said.
All 14 patients who received VX-880 "demonstrated islet cell engraftment and production of endogenous insulin," Vertex said.
"Two patient deaths, both unrelated to VX-880, have occurred," the drugmaker said. "Vertex has placed the study on a protocol-specified pause, pending review of the totality of the data by the independent data monitoring committee and global regulators."