VXX-401 / Vaxxinity - LARVOL DELTA

VXX-401, a novel anti-PCSK9 vaccine, reduces LDL-C in cynomolgus monkeys. (PubMed, J Lipid Res) - "A repeat-dose toxicity study conducted in NHP under good laboratory practices (GLP toxicity) indicated a suitable safety and tolerability profile, with injection site reactions being the main findings. As a promising safe and effective LDL-C lowering therapy, VXX-401 may represent a broadly accessible and convenient option to treat hypercholesterolemia and prevent ASCVD."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Metabolic Disorders

A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Administered IM in Adult Participants (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Vaxxinity, Inc. | N=48 ➔ 64 | Trial primary completion date: Nov 2023 ➔ Jun 2024

Enrollment change • Trial primary completion date • Dyslipidemia • Metabolic Disorders

A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Compared With Placebo in Adult Participants (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Vaxxinity, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Metabolic Disorders

A Study to Investigate the Safety, Tolerability, Immunogenicity, and Pharmacodynamics of VXX-401 Compared With Placebo in Adult Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Vaxxinity, Inc.

New P1 trial • Dyslipidemia • Metabolic Disorders

VXX-401, AN INVESTIGATIONAL PCSK9 VACCINE FOR THE PREVENTION OF CARDIOVASCULAR DISEASE (ACC-WCC 2023) - "VXX-401 is now advancing into clinical development, the Phase 1 trial will assess safety, immunogenicity and LDL-C reduction in healthy individuals with elevated serum LDL-C (> 100 mg/dL). As a potentially safe and effective LDL-C lowering therapy, VXX-401 may represent an affordable and convenient strategy to prevent ASCVD."

Atherosclerosis • Cardiovascular • Dyslipidemia • IFNG • IL4