[Asia Economy Reporter Lee Chun-hee] Celltrion's COVID-19 antibody treatment 'Rekkirona' has been shown to be significantly effective against the COVID-19 Delta variant (Indian variant) according to newly released research results.
Celltrion announced on the 26th that it has disclosed the efficacy verification results of animal efficacy tests of Rekkirona against the Delta variant virus through bioRxiv and has completed submission to the American Journal of Biochemistry and Biophysics Research 'BBRC'.
In a recent efficacy test on 49 experimental mice conducted by the Korea Disease Control and Prevention Agency, Celltrion confirmed that the viral titer significantly decreased in the Rekkirona-treated group compared to the control group, along with clinical improvements such as protection against weight loss.
Celltrion plans to continue releasing experimental results related to Rekkirona's responsiveness to COVID-19 variant viruses through cell line and animal tests, not only from this experiment. The company confirmed strong neutralizing ability against the rapidly spreading Delta variant worldwide through this animal experiment and also secured neutralizing ability results showing maintained neutralization against the Lambda variant, which is currently prevalent in South America, including Peru, compared to the wild-type virus.
Celltrion is strengthening its platform for variant response by completing clinical material production of the cocktail antibody 'CT-P63', discovered from various neutralizing antibody candidates secured during the development of the existing Rekkirona (CT-P59), and preparing to enter Phase 1 clinical trials.
Celltrion plans to continuously monitor Rekkirona's variant response trends and prepare for the commercialization of CT-P63 simultaneously. For major existing variants such as Alpha, Beta, Gamma, and Delta, whose neutralizing ability and therapeutic efficacy have been confirmed so far, Celltrion will respond with Rekkirona. Additionally, to ensure broad neutralizing ability against newly emerging variants beyond these, the company plans to add CT-P63 to its response strategy.
Celltrion is also actively upgrading the formulation of Rekkirona, which is currently used as an injectable. The company has signed a contract with the U.S. biotech company Inhalon Biopharma, which holds patents and technology related to inhalable antibody treatments, and has begun developing an inhalable form of Rekkirona.
The inhalable Rekkirona is being developed to deliver antibodies directly to the airway mucosa infected by the COVID-19 virus. By allowing easy administration of Rekkirona through an inhaler regardless of location, it is expected to greatly improve the convenience and accessibility of medication for COVID-19 patients. Currently, Inhalon started clinical trials of the inhalable Rekkirona last month in Australia.
Currently, Celltrion is proceeding with procedures for product approval from major global regulatory agencies based on safety and efficacy data confirmed in the global Phase 3 clinical trials of Rekkirona and various variant response test results. In Europe, the European Commission (EC) selected it as a 'promising COVID-19 treatment' last month, increasing the likelihood of approval, and Celltrion is maintaining close consultations with the U.S. Food and Drug Administration (FDA). On the 17th, Indonesia's National Agency of Drug and Food Control (BPOM) also granted Emergency Use Authorization (EUA) for Rekkirona.
A Celltrion official stated, "While global vaccination is actively underway, the spread of COVID-19 due to variant viruses is intensifying, making effective treatments essential. We will continue to verify Rekkirona's variant response capabilities to enable more patients to receive the treatment, and accelerate the development of treatments with improved administration convenience, so that Celltrion's treatments can play their role on the front lines of quarantine efforts."
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