Celltrion's Plant No. 2
South Korean pharmaceutical giant Celltrion has submitted for global review the results of an animal study which it said suggested the efficacy of its COVID-19 treatment Regkirona against the delta variant, the firm said Monday.
It also added that its US partner tasked with developing an inhaled version of the monoclonal antibody treatment also known as CT-P59 or regdanvimab has secured a $7 million funding from the US Army Medical Research & Development Command.
According to the company’s announcement on Monday, the animal test results of Regkirona have been submitted to the peer-reviewed journal Biochemical and Biophysical Research Communications.
In the test, conducted by the Korea Disease Control and Prevention Agency on 49 mice infected with the delta variant, Regkirona significantly reduced viral titer and prevented weight loss, Celltrion said. Data collected from the experiment was published earlier on bioRxiv, an open access preprint repository for biological scientists.
Earlier this month, Celltrion announced that Regkirona showed neutralizing activity against the Lambda variant, first found in Peru, citing a cell test conducted by the US National Institutes of Health.
The firm is pushing for clinical trials of another COVID-19 treatment candidate CT-P63, which it says could work against new variants that could emerge in the future.
It is currently preparing for phase 1 study of the new treatment candidate. It would also study a potential cocktail treatment involving CT-P63 and Regkirona, it added.
As the nebulized form of Regkirona, which would be the first of its kind if successfully developed, Celltrion said it will increase cooperation with its partner Inhalon Biopharma, which is the US-based clinical-stage immunotherapy company.
Inhalon plans to complete a Phase 1 clinical study of the nebulized Regkirona by the end of the year.
Last month, Celltrion disclosed top-line results from a global phase 3 clinical study of Regkirona, which was conducted with 1,315 patients from 13 countries. The study showed that the treatment has reduced the risk of cases progressing to severe COVID-19 by over 70 percent.
Regkirona is currently under rolling review by the European Medicines Agency. Celltrion is in talks with the US Food and Drug Administration for Emergency Use Authorization of Regkirona as well.
By Shim Woo-hyun (email@example.com