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

● Following positive interim results of the Phase I clinical trial of CT-P591, the Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion’s Investigational New Drug (IND) application to initiate a Phase II/III pivotal trial of the potential treatment in mild-to-moderate patients

● The global Phase II/III trial is set to enrol 1,000 patients from up to 12 countries to investigate the safety and efficacy of CT-P59

● Celltrion expects to apply for emergency use authorisation (EUA), conditional on the results

September 17, 2020 09:33 AM Eastern Daylight Time

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The global trial will evaluate the safety and efficacy of CT-P59 in patients with mild-to-moderate symptoms of SARS-CoV-2 infection. Celltrion is set to obtain the summary of the primary results for Phase II of the study by the end of the year.

Celltrion has submitted the IND application for the clinical trial in 6 countries including Korea, the U.S and Spain, and plans to enrol more than 1,000 patients from up to 12 countries. The company expects to be able to apply for emergency use authorisation (EUA), conditional on the results of the pivotal trial.

Celltrion has begun manufacturing the process validation batch of CT-P59 and plans to increase manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate.

“Given that COVID-19 represents a significant global threat to life, there is an urgent need to identify treatments that can help stabilise our response to the pandemic. 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. Sang Joon Lee, Senior Executive Vice President of Celltrion.

As part of its efforts to address the pandemic, Celltrion has also initiated an ongoing in-human global Phase I clinical trial of CT-P59 in mild COVID-19 patients, and plans to investigate the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients as part of a prevention clinical trial.

- ENDS -

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-192,3

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 neutralizing 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 Celltrion announces positive interim results from Phase I trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate [Press Release] Retrieved from https://www.businesswire.com/news/home/20200911005199/en/Celltrion-Announces-Positive-Interim-Results-Phase-Trial

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