Domestic Antibody Therapeutics Written in Advance Before Approval... Additional Evaluation Needed for Variant Virus Effectiveness
[Asia Economy Reporter Choi Dae-yeol] The National Institute of Infectious Diseases under the Korea National Institute of Health announced on the 14th that it has decided to conduct investigator-initiated clinical trials on the antibody treatment currently being developed by Celltrion. Although approval has not yet been granted, it can be administered to elderly or high-risk patients based on medical staff judgment.
At a briefing on the 14th, Jang Hee-chang, director of the Infectious Disease Research Institute, said, "Based on the results so far, the National Institute of Infectious Diseases has consulted with the Ministry of Food and Drug Safety (MFDS) about administering the treatment to elderly and high-risk patients if deemed necessary by medical personnel even before MFDS approval. We surveyed the demand for investigator-initiated clinical trials through the Korean Society of Infectious Diseases," adding, "75 investigators from 35 medical institutions requested clinical trials."
Accordingly, the society designated a joint clinical trial review committee to promptly conduct investigator-initiated clinical trials and administer the treatment to frontline patients. This treatment candidate, developed with government support, recently completed phase 2 clinical trials and has applied to the MFDS for phase 3 trials and conditional approval, which is currently under review.
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Director Jang stated, "One consideration in applying the antibody treatment is that its efficacy may decrease if spike protein variants emerge," adding, "We have evaluated the neutralizing ability against virus strains that have circulated domestically so far and confirmed that the neutralizing ability is maintained." He further said, "We plan to additionally evaluate the neutralizing ability against virus strains imported from the UK and South Africa."
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