Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK
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Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19
antiviral antibody treatment, CT-P59, in the UK
· The UK Medicines and Healthcare products Regulatory Agency (MHRA)approved Celltrion’s clinical trial authorization (CTA) application to initiatea Phase I trial of CT-P59, a potential COVID-19 antiviral antibody treatment
· Celltrion’s Phase I trial will enroll patients with mild symptomsof SARS-CoV-2 infection to evaluate the safety, tolerability, efficacy,pharmacokinetics and immunogenicity of CT-P59; a Phase I clinical trial in healthyvolunteers is ongoing in South Korea
· Celltrion anticipates results from Phase II/III trials by the endof the year with commercial production set to commence this September
JULY 30th 2020, INCHEON, KOREA – Celltrion Group announced that the UK Medicines andHealthcare products Regulatory Agency (MHRA) has approved the company’sClinical Trial Authorisation (CTA) application for a Phase I clinical trialwith CT-P59, a COVID-19 antiviral antibody treatment candidate, in patientswith mild symptoms of SARS-CoV-2 infection. The clinical trial is set toevaluate the safety, tolerability, efficacy, pharmacokinetics andimmunogenicity of CT-P59.
Celltrion plans to conduct further global Phase II/IIItrials in patients with mild and moderate COVID- 19 and anticipates resultsfrom these pivotal studies by the end of the year. Furthermore, a clinical trialinvestigating the use of CT-P59 as a preventative measure, by enrolling peoplein close contact with COVID-19 patients globally, is also planned and thetopline data for this trial are anticipated in Q1 of 2021.
Celltrion will start the full-scale commercial productionof CT-P59 in September this year and is securing sufficient manufacturingcapacity to produce enough of the potential COVID-19 treatment for up to 5million patients a year.
“This is a timely approval from the UK regulatoryauthority for the Phase I clinical trial with CT-P59 as the global pandemiccontinues to grow and there remains a significant need for a safe and effectivetreatment for COVID-19,” said Dr. Sang Joon Lee, Senior Executive VicePresident of Celltrion. “We are rapidly advancing our COVID-19 programme withCT-P59, including a Phase I clinical trial in healthy volunteers in Korea.Furthermore, we are making efforts to ensure that if the clinical trial programmeis successful we are able to scale up manufacturing appropriately.”
CT-P59 was identified as a potential treatment forCOVID-19 through screening of antibody candidates and selecting those thatshowed the highest potency in neutralising the SARS-CoV-2 virus including themutated G-variant strain (D614G variant). In pre-clinical data the treatment candidatedemonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as areduction in lung inflammation.1
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Notes to Editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovativeand affordable medications to promote patients’ access to advanced therapies.Its products are manufactured at state-of-the-art mammalian cell culturefacilities, designed and built to comply with the US FDA cGMP and the EU GMPguidelines. Celltrion Healthcare endeavours to offer high-qualitycost-effective solutions through an extensive global network that spans morethan 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 toillnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2is responsible for the disease COVID-19, this new strain, discovered in 2019,is behind the ongoing pandemic outbreak. The most common signs of COVID-19include fever, dry cough and tiredness; however, people may
also experience other symptoms including shortness ofbreath and breathing difficulties. Most people infected with the virus willexhibit mild to moderate symptoms however older people, and those with existingunderlying conditions such as cardiovascular disease and diabetes are more likelyto develop a more severe form of COVID-19.
Please find up to dateinformation about the outbreak via the World Health Organization at
https://www.who.int/health-topics/coronavirus#tab=tab_1
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References
1Celltrion. Data on file
2 Coronavirus. World HealthOrganization.Available at: https://www.who.int/healthtopics/coronavirus#tab=tab_1Last accessed: July 2020
3 Coronaviruses. National Institute ofAllergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronavirusesLast accessed: July 2020