CT-P59

Celltrion presents efficacy and safety data for potential COVID-19 treatment candidate CT-P59 in patients with mild symptoms

Retrieved on: 
Friday, November 6, 2020
Infectious diseases, Pharmaceutical, Health, Clinical trials, Respiratory diseases, Occupational safety and health, Atypical pneumonias, Coronavirus disease, Zoonoses, Infectious diseases, Medicine, Severe acute respiratory syndrome, Celltrion Healthcare, COVID-191,2, CT-P59

Celltrion Group announced results from the ongoing Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.

Key Points: 
  • Celltrion Group announced results from the ongoing Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.
  • The data presented at the 2020 fall Conference of the Korean Society of Infectious Diseases on 5th November 2020, demonstrated promising safety, tolerability, antiviral effect, and efficacy profile of CT-P59 in patients with mild symptoms of COVID-19.
  • The trial enrolled 18 patients with mild symptoms of SARS-COV-2 infection who were randomised into three cohorts in which 15 patients received CT-P59 at 20mg/kg, 40mg/kg or 80mg/kg respectively, or matching placebo (3 patients).
  • This is positive and encouraging efficacy and safety data showing accelerated recovery time in patients with mild symptoms of COVID-19, said Professor Jin Yong Kim, Division of Infectious Diseases, Department of Internal Medicine, Incheon Medical Centre.

Celltrion Initiates Post-exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59

Retrieved on: 
Monday, October 12, 2020
Health, Infectious diseases, Clinical trials, Research, Pharmaceutical, Science, Zoonoses, Celltrion, Coronavirus disease, Articles, Life sciences, Industries, Celltrion Healthcare, COVID-191,2, CT-P59

Celltrion Group today announced the launch of its Phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate as a preventative measure.

Key Points: 
  • Celltrion Group today announced the launch of its Phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate as a preventative measure.
  • Celltrion anticipates the enrolment of approximately 1,000 patients to evaluate population-based prophylaxis in contacts of SARS-CoV-2 infected patients.
  • The post-exposure prophylaxis clinical trial will evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.
  • Celltrion has previously shown promising safety results in the Phase I clinical trial in healthy volunteers.

Celltrion receives Korean MFDS approval to initiate Phase II/III pivotal trial of an anti-COVID-19 monoclonal antibody treatment candidate, CT-P59

Retrieved on: 
Thursday, September 17, 2020
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Monoclonal antibodies, Celltrion, Life sciences, Biotechnology, Industries, Celltrion Healthcare, COVID-192,3, CT-P59

Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the companys Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.

Key Points: 
  • Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the companys Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.
  • Celltrion is set to obtain the summary of the primary results for Phase II of the study by the end of the year.
  • The company expects to be able to apply for emergency use authorisation (EUA), conditional on the results of the pivotal trial.
  • The initiation of the global Phase II/III pivotal trial of CT-P59 is an important step forward, and together with the ongoing Phase I trial in patients with mild symptoms, Celltrion remains committed to investigating a potential anti-COVID-19 monoclonal antibody treatment, said Dr.

Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate

Retrieved on: 
Friday, September 11, 2020
Health, Infectious diseases, Clinical trials, Research, Pharmaceutical, Science, Monoclonal antibodies, Health, Articles, Drugs, Celltrion, Coronavirus disease, COVID-19 drug development, Ieramilimab, Celltrion Healthcare, COVID-192,3, CT-P59

Celltrion Group announced today interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.

Key Points: 
  • Celltrion Group announced today interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.
  • Should we receive positive results from our series of ongoing clinical trials, we intend to request emergency use authorisation for our drug.
  • Celltrion has initiated an in-human, global, Phase I clinical trial of CT-P59 in mild COVID-19 patients and plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea.
  • The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021.