LDL Lowering Vaccine Candidate Launches Phase 1 Study

Vaxxinity, Inc. today announced that the first subjects had been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor contributing to heart disease.

Heart disease remains the leading cause of death globally, claiming over 18 million deaths yearly.

VXX-401 is designed to induce robust, long-acting antibodies against PCSK9 to lower LDL cholesterol.

The multicenter Phase, 1 dose-escalation trial, aims to enroll 48 subjects aged 18 to 75 years with LDL cholesterol between 2.59 and 4.89 mmol/L.

The trial evaluates safety, tolerability, and immunogenicity (as measured by serum anti-PCSK9 antibody titers).

LDL cholesterol levels will measure the pharmacodynamics of the immune response, an established model of PCSK9 inhibition in hypercholesterolemia. This study was last updated on March 16, 2023.

VXX-401 was designed using Vaxxinity's proprietary synthetic peptide vaccine platform and is being developed to treat hypercholesterolemia.

The platform is designed to harness the immune system to convert the body into its own natural "drug factory," stimulating the production of antibodies.

"This is an exciting milestone for VXX-401 and Vaxxinity in our pursuit to vaccinate the world against heart disease with a preventative option that is convenient and accessible, addressing an unmet need to combat the leading global cause of death," said Mei Mei Hu, Chief Executive Officer of Vaxxinity, in a press release on March 20, 2023.

"PCSK9 antibody therapies are well-tolerated and effective, but huge, unmet patient need remains."

"In order to solve the problem of heart disease, the world needs a scalable, accessible technology that can reach the hundreds of millions, if not billions, of people at risk."

"With an LDL-lowering vaccine, we can offer an option that's cost-effective, safe, convenient, long-acting, and deployable."