Pfizer and Vivet on go with mid-stage VTX-801 study in liver disorder

• Pfizer and privately held Vivet Therapeutics said the FDA has cleared Vivet’s Investigational New Drug (IND) application for the GATEWAY study, a Phase 1/2 clinical trial evaluating Vivet’s gene therapy vector, VTX-801, for the potential treatment of Wilson disease (WD), a rare and life-threatening liver disorder. The trial is expected to commence in early 2021.
• The GATEWAY trial will measure relevant biomarkers to evaluate physiological restoration of copper elimination and transport in patients.
• The primary endpoint is to assess the safety and tolerability of VTX-801 at 52 weeks after a single infusion.
• Vivet Therapeutics expects to enroll the first patient in early 2021.
• In March 2019, Pfizer acquired 15% ownership stake in Vivet and secured an exclusive option to acquire all outstanding shares.
• In September 2020, Vivet and Pfizer inked manufacturing agreement for the VTX-801.
• https://seekingalpha.com/news/3637354-pfizer-and-vivet-on-go-mid-stage-vtxminus-801-study-in-liver-disorder