CELLTRION

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 5^th November 2020, demonstrated promising safety, tolerability, antiviral effect, and efficacy profile of CT-P59 in patients with mild symptoms of COVID-19.

The global Phase I clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the safety, tolerability and antiviral effect of CT-P59. 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).

The results indicate that the patient population treated with CT-P59 experienced about 44% reduced mean clinical recovery time in comparison to the average placebo recovery time. None of the patients treated with CT-P59 required hospitalisation or antiviral therapy as a result of COVID-19. No significant treatment-emergent serious adverse events or clinically significant treatment-emergent adverse events were identified at the interim stage.

“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. “I look forward to the possibility of further promising data from ongoing phase II/III studies building on the positive results seen in this study.”

Celltrion has previously submitted the Investigational New Drug (IND) application for the clinical trial globally, and plans to conduct further global Phase II and III trials including Korea. In addition, Celltrion has also initiated a post-exposure prophylaxis clinical trial of CT-P59 to evaluate the candidate as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients.

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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-19^1,2

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.³

References

¹ Coronavirus. World Health Organization . Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: November 2020

² Coronaviruses. National Institute of Allergy and Infectious Diseases . Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: November 2020

³ Celltrion. Data on file

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