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PF 07285557 discontinued for CV risk reduction and hypertriglyceridemia.

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Published:1st Feb 2022
Pfizer and Ionis Pharmaceuticals announced the discontinuation of the Pfizer-led clinical development program for PF 07285557 (vupanorsen), an investigational antisense therapy that was being evaluated for potential indications in cardiovascular (CV) risk reduction and severe hypertriglyceridemia (SHTG).

Pfizer made this decision after a thorough review of data from the global Phase IIb, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 8-arm parallel-group study of vupanorsen in statin-treated participants with dyslipidemia — also known as TaRgeting ANGPTL3 with an aNtiSense oLigonucleotide in AdulTs with dyslipidEmia (TRANSLATE-TIMI 70).

As previously announced, the study met its primary endpoint, achieving a statistically significant reduction in non-high density lipoprotein cholesterol (non-HDL-C) — as well as statistically significant reductions in triglycerides (TG) and angiopoietin-like 3 (ANGPTL3). However, the magnitude of non-HDL-C and TG reduction observed did not support continuation of the clinical development program for CV risk reduction or SHTG. Vupanorsen was also associated with dose-dependent increases in liver fat, and higher doses were associated with elevations in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Pfizer will return development rights to vupanorsen to Ionis, from which it licensed the investigational therapy in a worldwide exclusive agreement in November 2019.

Condition: Dyslipidaemia
Type: drug

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