Vertex Pharmaceuticals will not advance clinical trials of a treatment for Type 1 diabetes after efficacy data failed to support further clinical advancement.
There were two primary endpoints in Part B of the VX-264 trial: safety and change in peak C-peptide during a mixed-meal tolerance test, the company said Friday. The study did not meet the efficacy endpoint because increases in C-peptide, a marker of insulin production, were not observed at levels necessary to deliver a benefit.
The Boston biopharmaceutical company plans to conduct more analyses, including of explanted devices, to better understand the findings.
A pivotal trial of Zimislecel, a fully differentiated islet cell therapy with standard immunosuppression, is on track to complete enrollment and dosing in the first half of this year. Vertex expects to submit marketing applications for that treatment to global regulators in 2026.
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