Celltrion announces positive pre-clinical results for COVID- 19 antiviral antibody treatment, showing improvement in recovery time

·          Pre-clinical data for Celltrion’s antiviral antibody treatment candidate demonstrate a 100-fold reduction in viral load of SARS-CoV-2 (COVID-19), as well as improvement in lung lesions

·          The antiviral activity at the pre-clinical stage indicates Celltrion’s candidate could be a potential treatment for COVID-19 if the results are replicated in clinical trials

·          The first in-human clinical trials for Celltrion’s antiviral antibody candidate are set to start in July

JUNE 1 2020, 10:00 KST, INCHEON, KOREA – Celltrion Group today announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARS-CoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models.

The pre-clinical study was conducted in an animal model in collaboration with one of the Korean National Universities, Chungbuk National University College of Medicine. The trial set out to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. In comparison to the placebo-controlled group, the research team observed improved recovery in terms of clinical symptom scores such as runny nose, cough and body aches, after the first day of treatment. From the fifth day, significant clinical remission was observed.

Reverse transcriptase polymerase chain reaction (RT-PCR) measurement and cell culture-based viral diagnosis were used to analyse specimens from the upper respiratory tract (nasal discharge and nasal turbinate) and the lungs. The samples from the high-dose group saw the viral load reduce by 100-fold. Furthermore, lung biopsy showed that both dosage groups saw inflammation returning to normal lung tissue histopathology within 6 days as well as a shortened recovery time, whereas the placebo-controlled group experienced sustained levels of lung inflammation and complications.

This announcement follows the identification of antibody candidates for an antiviral treatment which Celltrion completed in April. In response to these positive results, Celltrion will now conduct additional efficacy and toxicity testing in pre-clinical settings and anticipates starting first-in-human clinical trials in July.

“Celltrion is drawing on its expertise, innovation and previous experience in coronaviruses, such as efforts researching the efficacy of CT-P38, an investigational antibody to treat Middle East Respiratory Syndrome (MERS), as well as CT-P27, a multi-antibody drug for influenza which is being tested in a phase 2b study, to develop a safe and effective treatment for COVID-19,” said Ki-Sung Kwon, Head of R&D Unit at Celltrion. “Celltrion is leveraging its advanced technologies to lead efforts to develop a novel antiviral antibody treatment containing potent therapeutic antibodies that can neutralise the virus. Celltrion hopes to commence first-in-human clinical trials in July and has the capability to roll out mass production of the therapeutic antibody treatment once it is ready.”

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^[i],[ii]

Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). 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.

There are currently no specific vaccines or treatments approved for 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

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

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