Celltrion initiates phase I trial of COVID-19 antibody treatment

By The Science Advisory Board staff writers

August 26, 2020 -- The Korean Ministry of Food and Drug Safety has approved Celltrion's investigational new drug application for a phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate.

The trial has already begun enrolling patients with mild symptoms to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CT-P59. CT-P59 was identified through screening of antibody candidates and the selection of those with the highest potency in neutralizing SARS-CoV-2 in preclinical development.

The company expects study results from phase II/III trials in patients with mild symptoms, phase III trial in severe-to-moderate COVID-19 patients, and a prevention clinical trial by the end of 2020.

Preparation for a phase I study in healthy volunteers in South Korea has been completed, and the company expects this trial to be completed later this year.

In July, the company began a clinical trial of CT-P59 in the U.K. following a clinical trial authorization from the U.K. Medicines and Healthcare products Regulatory Agency.

HiFiBio submits IND for SARS-CoV-2 treatment
HiFiBio Therapeutics has submitted an investigational new drug (IND) application with the U.S. Food and Drug Administration for novel SARS-CoV-2 neutralizing...
AbbVie, Harvard partner on $30M emerging virus research
AbbVie and Harvard University announced a $30 million collaborative research alliance to study therapies against emerging viral infections.
Regeneron, Roche increase supply of COVID-19 antibody cocktail
Regeneron Pharmaceuticals and Roche are joining forces to develop, manufacture, and distribute Regn-COV2, Regeneron's investigational antiviral antibody...
Companies work to develop combo mAb, NK cell COVID-19 therapy
A new research project is bringing together universities and pharmaceutical companies to collaborate on the development of a combination of a monoclonal...

Copyright © 2020 scienceboard.net


Conferences
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter