Korea approves Celltrion’s Phase 1 trial of COVID-19 antiviral antibody treatment

pharmafile | August 28, 2020 | News story | Medical Communications COVID-19, antibodies, coronavirus vaccine 

Celltrion Group has announced that the Korean Ministry of Food and Drug Safety has approved the company’s Investigational New Drug application for a Phase 1 trial for their coronavirus antiviral antibody treatment candidate.

Celltrion has already begun trials of the treatment, called CT-P59, in July following their clinical trial authorisation application from the UK’s Medicines and Healthcare products Regulatory Agency.

For its Korean trial, it has begun to enroll patients with mild symptoms of COVID-19, and the trial is designed to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59. Celltrion is planning to conduct Phase 2 and 3 trials in coronavirus patients with mild symptoms, another Phase 3 trial in patients with moderate to severe COVID-19, and a prevention clinical trial by the end of the year.

Dr Sang Joon Lee, Senior Executive Vice President of Celltrion, said: “We are extremely encouraged by the consistent progress we are making in preparation for our CT-P59 clinical trials in various settings, and we remain on track to reach our upcoming milestones.”

CT-P59 works by neutralising the virulent D614G variant of COVID-19, which is the strain associated with increased viral transmission of the virus. The company completed the halfway point of developing the treatment in March, after building a 300-antibody library from blood samples that were collected from recovered coronavirus patients.

Conor Kavanagh

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