Celltrion Antibody Treatment 'Rekkirona' Completes Global Phase 3 Clinical Trial Dosing

Published 26 Apr.2021 08:47(KST)

Celltrion COVID-19 Antibody Treatment 'Rekkirona' (Provided by Celltrion)

[Asia Economy Reporter Lee Chun-hee] Celltrion announced on the 26th that it has completed the recruitment and administration of patients for the global Phase 3 clinical trial of its COVID-19 antibody treatment, 'Rekkirona.'

Celltrion began patient enrollment for the Phase 3 trial in January and recently completed recruitment and administration of the target 1,300 patients across 13 countries, including South Korea, the United States, Spain, and Romania. Initially, Celltrion set the clinical target at 1,172 patients but finalized the recruitment number at 1,300 to secure safety and efficacy data from a larger patient population.

Celltrion stated that among the patients who have completed administration so far, there have been no cases of safety concerns or study discontinuation due to adverse reactions following administration.

Celltrion is actively emphasizing the safety of Rekkirona in ongoing export discussions and plans to analyze the Phase 3 clinical data and derive results by the end of June to submit to domestic and international regulatory authorities. Through this, it is expected that the review process for the current approval applications will be further accelerated.

Currently, Rekkirona received conditional approval from the Ministry of Food and Drug Safety in February for administration to high-risk mild and moderate patients aged 60 or older or those with underlying conditions (one or more of cardiovascular disease, chronic respiratory disease, diabetes, or hypertension). If the safety and efficacy of Rekkirona are proven in this large-scale global Phase 3 trial, the target patient group for administration is expected to expand further.

A Celltrion official said, "COVID-19 is still prevalent in several countries, and thanks to the great efforts of our headquarters clinical team and local staff, we were able to recruit a sufficient number of patients in a short period. We expect that ongoing export-related discussions will gain momentum, and we will focus our capabilities on producing excellent results through the analysis of Phase 3 clinical data in the first half of this year."