MFDS: "GC Green Cross Fails to Demonstrate Effectiveness of COVID-19 Plasma Therapy... Conditional Approval Denied"

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[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety (Director Kim Kang-lip) has concluded that it is not appropriate to grant conditional approval for GC Green Cross's COVID-19 plasma fractionation treatment 'Zicoviddic Injection (Anti-COVID-19 Human Immunoglobulin)'.

On the 11th, the Ministry held a meeting of the 'COVID-19 Therapeutics and Vaccines Safety and Efficacy Verification Advisory Committee' and evaluated the data from one domestic early Phase 2 (2a) clinical trial submitted by GC Green Cross, reaching this judgment. Five experts, including infectious disease specialists and clinical statistics experts, attended the verification advisory committee meeting.

Zicoviddic Injection is a plasma fractionation treatment made by concentrating antibodies in the blood of patients recovering from COVID-19 infection at high concentrations.

The submitted clinical trial data involved 63 patients at 12 clinical trial institutions, divided into a patient group receiving placebo (normal saline) in an open-label, randomized manner (control group, 17 patients) and patient groups receiving three doses of the investigational drug (test groups: 2,500 mg 15 patients, 5,000 mg 15 patients, 10,000 mg 16 patients). The approved dosage applied for is a single intravenous administration of 10,000 mg.

The submitted early Phase 2 clinical trial was a therapeutic exploratory clinical trial aimed at identifying an appropriate therapeutic dose and evaluating therapeutic potential.

The submitted early Phase 2 clinical trial was evaluated using 11 exploratory efficacy endpoints to assess therapeutic potential; however, no primary efficacy endpoint was set nor statistical testing conducted to prove therapeutic effect.

Evaluation results showed that there was generally no observed difference in effect between the test groups and control group across 11 exploratory efficacy endpoints, including clinical symptom improvement, mortality rate, days of oxygen therapy, hospitalization days, and viral negativity.

The verification advisory committee judged that, considering the submitted data comprehensively, the early Phase 2 clinical trial results presented only exploratory efficacy evaluation results as originally planned and did not demonstrate proven therapeutic effects.

Additionally, due to the small number of subjects, uneven allocation between control and test groups, and limitations such as the inability to exclude the effects of standard treatments using existing COVID-19 therapeutics in the open-label trial, it was deemed inappropriate to approve this drug on the condition of conducting a Phase 3 clinical trial. The committee recommended that additional clinical trial results confirming therapeutic effects be submitted for approval review in the future.

Adverse reactions occurred in 21 patients (45.65%) in the overall test groups and 3 patients (17.65%) in the control group, mostly mild to moderate; however, there were 3 deaths and 2 infusion-related adverse reactions only in the test groups. Two deaths were reported as unrelated to the drug, and one death was assessed as having an indeterminate relationship with the drug. Infusion-related adverse reactions were fever and erythema, all mild.

Adverse reactions of interest such as thrombosis, renal failure, and renal dysfunction, which are reported in immunoglobulin products like Zicoviddic Injection, were not reported in either the test or control groups.

The verification advisory committee noted that although 3 deaths occurred in the test groups, considering patients' underlying diseases, severity of COVID-19, and the small number of subjects, it is difficult to draw a clear conclusion on safety, and careful monitoring of adverse reactions is necessary in subsequent clinical trials.

The Ministry of Food and Drug Safety stated, "According to the results of this verification advisory committee meeting, the next step in the triple advisory process for COVID-19 therapeutics and vaccines, the Central Pharmaceutical Review Committee meeting, will not be held. If subsequent clinical trials for Zicoviddic Injection are planned, we will support their thorough design."

This content was produced with the assistance of AI translation services.