- Vaxxinity Inc announced data demonstrating durable lowering of low-density lipoprotein (LDL) cholesterol in non-human primates.
- The company also selected VXX-401 to pursue as its anti-PCSK9 vaccine candidate to treat hypercholesterolemia.
- The company plans to start Phase 1 clinical trial in early 2023.
- VXX-401 is a synthetic peptide vaccine that targets proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) to lower low-density lipoprotein (LDL) cholesterol, a mechanism proven to reduce the risk of cardiovascular events.
- The new data in non-human primates demonstrate that VXX-401 is well tolerated and provides long-lasting, significant LDL reduction versus placebo.
- After a 6-week priming regimen with VXX-401, LDL cholesterol progressively dropped to 40-50% of placebo values in healthy monkeys.
- A steady-state reduction of LDL cholesterol was observed for months. The magnitude of LDL reduction with VXX-401 was similar to that of a single dose of a monoclonal antibody comparator.
- While LDL levels returned to baseline within 2-3 weeks after a single dose of a monoclonal antibody, a steady-state and long-lasting reduction of LDL levels was observed after the last dose of VXX-401.
- Levels of "good" high-density lipoprotein (HDL) cholesterol were not affected by treatment and remained stable.
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