South Korean company Celltrion has reported data from Phase II clinical trials confirming that its Covid-19 treatment candidate, Regkirona (CT-P59; regdanvimab), demonstrated better therapeutic efficacy than other antibody treatments.
Korea BioMed quoted Celltrion research and development unit head Kwon Ki-sung as saying in an online seminar: “We have confirmed that Regkirona showed a better efficacy compared to the existing antibody treatments developed by Eli Lilly and Regeneron in the study, and doctors who conducted the trials agreed with the excellent therapeutic effect.”
Kwon added that the drug should be given immediately after the patient develops symptoms and the early-phase patients will experience the drug’s efficacy as it can be administered within seven days of symptom onset.
The company carried out Phase II clinical trials of the drug in over 50 hospitals in various countries, including Korea, US, Spain and Romania.
A total of 327 mild and moderate Covid-19 patients were part of the trial conducted from 27 September to 25 November last year.
The research team validated the drug’s effectiveness by obtaining a sample from patients and analysing the time taken to produce a negative Covid-19 diagnostic test result and assessing it with those who did not receive Regkirona.
Korea BioMed reported that Celltrion will present study details at the Pharmaceutical Society of Korea hosted the 2021 High1 New Drug Development Symposium.
Celltrion had applied for Conditional Marketing Authorisation (CMA) for CT-P59 to the Korean Ministry of Food and Drug Safety (MFDS) in December.
The Ministry of Food and Drug Safety (MFDS) will conclude reviewing for preliminary use authorisation by confirming the safety and efficacy profile by mid-February.
Furthermore, if Regkirona obtains the regulatory approval, Celltrion will proceed with the Phase III trials and present the data to the ministry.
Last November, Celltrion completed enrolment of 327 patients with mild-to-moderate SARS-CoV-2 infection symptoms to evaluate CT-P59 in the global Phase II clinical trial.