INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group today announced enrolment completion of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Celltrion anticipates submission for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial.

The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) and Celltrion is set to obtain the results for global Phase II trial. In addition, Celltrion plans to initiate a global Phase III clinical trial in more than 10 countries in order to obtain more comprehensive safety and efficacy results of CT-P59.

“We managed to successfully enrol 327 patients for the global Phase II trial and the results from the trial are expected in the coming weeks. We plan to compile a robust data set to support the planned emergency use application, expected as early as the end of the year, subject to positive study results,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “In order to respond to the global pandemic threat, we are moving forward with our clinical development with the highest urgency and as a key priority.”

In an effort to further address the pandemic, Celltrion has also initiated a post-exposure prophylaxis clinical trial to evaluate the preventive effect and safety of CT-P59 and identify whether this antibody treatment candidate can elicit a neutralising antibody response to prevent the virus from infecting human cells.

Celltrion is also working to increase its manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate, ensuring potential delivery for as many as 2 million people per year globally.

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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-191,2

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 (Regdanvimab)

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