Journal Article

Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection

Jung, Na Hyun, Lee, Seul Gi, Kim, Min Kyung, Streinu-Cercel, Adrian, Săndulescu, Oana, Lee, Sang Joon, Kim, Sung Hyun, Jeon, Da Bee, Kim, Bum Soo, Kim, Yeon-Sook, Hong, Jang Hee, Streinu-Cercel, Anca, Kim, Jin Yong, Jung, Jin Gyu, Jang, Young Rock, Lee, Yeo Jin, Park, Jae-Hyeong, Lee, Yeon Mi, Park, Jeong Eun

2021

Overview

•Study 1.1, in healthy volunteers, demonstrated safety and PK profile of CT-P59.•Study 1.2, in mild COVID-19 patients, also included virologic and clinical efficacy .•There were no IRRs or anaphylactic events with CT-P59 in either study.•CT-P59 reduced viral titers more than placebo in patients with >105 copies/mL.•Time to clinical recovery of COVID-19 symptoms was shorter with CT-P59 vs placebo. Neutralizing antibodies can reduce SARS-CoV-2 cellular entry, viral titers, and pathologic damage. CT-P59 (regdanvimab), a SARS-CoV-2 neutralizing monoclonal antibody, was examined in 2 randomized, double-blind, placebo-controlled, single ascending dose, Phase I studies. In study 1.1, healthy adults were sequentially enrolled to receive CT-P59 10, 20, 40, or 80 mg/kg or placebo. In study 1.2, adult patients with mild SARS-CoV-2 infection were enrolled to receive CT-P59 20, 40, or 80 mg/kg or placebo. Primary objectives of both studies were safety and tolerability up to day 14 after infusion. Secondary end points included pharmacokinetic properties. Study 1.2 also measured virology and clinical efficacy. Thirty-two individuals were randomized to study 1.1 (6 per CT-P59 dose cohort and 8 in the placebo cohort). By day 14 after infusion, adverse events (AEs) were reported in 2 individuals receiving CT-P59 20 mg/kg (headache and elevated C-reactive protein levels) and 1 receiving CT-P59 40 mg/kg (pyrexia) (all Common Terminology Criteria for Adverse Events grade 1). In study 1.2, 18 patients were randomized (5 per dose cohort and 3 in the placebo cohort). Sixteen AEs were reported in 10 patients receiving CT-P59. No AEs in either study led to study discontinuation. Greater reductions in viral titers were reported with CT-P59 than placebo in those with maximum titers >105 copies/mL. Mean time to recovery was 3.39 versus 5.25 days. CT-P59 exhibited a promising safety profile in healthy individuals and patients with mild SARS-CoV-2 infection, with potential antiviral and clinical efficacy in patients with mild SARS-CoV-2 infection. ClinicalTrials.gov identifier: NCT04525079 (study 1.1) and NCT04593641 (study 1.2).

• Publisher: Elsevier Inc,Elsevier Limited,Published by Elsevier Inc
• Subject: Adult / Adverse events / Antibodies, Monoclonal - adverse effects / Antibodies, Monoclonal, Humanized / Antibodies, Neutralizing / Antiviral drugs / C-reactive protein / Carrier Proteins / Clinical trials / COVID Original Research / COVID-19 / CT-P59 / Double-Blind Method / Drug dosages / Fever / Health care / Humans / Immunoglobulin G / Infections / Internal Medicine / Monoclonal antibodies / neutralizing monoclonal antibody / Patients / Pharmacists / Pharmacokinetics / Placebos / Proteins / Public health / regdanvimab / Safety / SARS-CoV-2 / Severe acute respiratory syndrome coronavirus 2 / Terminology