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

CT-P59 demonstrated a reassuring safety profile in Celltrion�s Phase I trial
The company anticipates enrolment of 500 patients from 12 countries for the global Phase II and III trials
Celltrion has also launched commercial production of CT-P59 as part of the preparation process

INCHEON, Korea–(BUSINESS WIRE)–Celltrion Group announced today interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The results showed a promising safety, tolerability and pharmacokinetics profile of CT-P59.

The Phase I clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects.¹ The results demonstrated no significant drug-related adverse events (AEs), and importantly there were no adverse events from the maximum tolerated dose cohort.

Along with these promising safety results, we have launched commercial production of CT-P59 this month to ensure, if trials are successful, we can meet the urgent global demand for a safe and effective antiviral treatment against COVID-19, said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. 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. Celltrion anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial, investigating the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients. The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021.

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Notes to Editors:

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

About COVID-19^2,3

Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.

The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.

Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1

About CT-P59

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.⁴

References

¹ ClinicalTrials.gov. A Phase 1, randomized, double-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects. Available at: https://clinicaltrials.gov/ct2/show/NCT04525079?term=celltrion&cond=covid+19&cntry=KR&draw=2&rank=1 Last accessed: September 2020

² Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: September 2020

³ Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: September 2020

⁴ Celltrion. Data on file