11 September 2020 - - South Korea-based biopharmaceutical company Celltrion Group has released interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, the company said.

The results showed a promising safety, tolerability and pharmacokinetics profile of CT-P59.

The Phase I clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects.

The results demonstrated no significant drug-related adverse events, and importantly there were no adverse events from the maximum tolerated dose cohort.

Celltrion has initiated an in-human, global, Phase I clinical trial of CT-P59 in mild COVID-19 patients and plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea.

Celltrion anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial, investigating the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients.

The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021.

Celltrion Healthcare's products are manufactured at mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines.

Celltrion Healthcare endeavours to offer 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.