Therapy Areas: Diabetes
Celltrion Receives Korean MFDS Approval to Initiate Phase II/III Pivotal Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59
17 September 2020 - - The Korean Ministry of Food and Drug Safety has approved South Korea-based Celltrion Group's Investigational New Drug application for a Phase II/III pivotal clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, the company said.

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 six 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, 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.

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.

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.

Coronaviruses 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.

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.
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