Unable to Demonstrate Effectiveness in 11 Exploratory Validity Evaluation Indicators
[Asia Economy Reporter Seo So-jung] 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 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 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 across 12 clinical trial institutions, divided into a placebo group (control group, 17 patients) receiving placebo (saline) via an open-label, randomized method, and test groups receiving three doses of the investigational drug (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.
No difference in efficacy between test and control groups in early Phase 2 clinical trial
The submitted early Phase 2 clinical trial was a therapeutic exploratory trial aimed at identifying an appropriate therapeutic dose and evaluating treatment potential.
The early Phase 2 clinical trial used 11 exploratory efficacy endpoints to evaluate treatment potential, but no primary efficacy endpoint was set nor statistical testing conducted to prove treatment efficacy.
Evaluation results showed no overall difference in efficacy between the test and control groups across 11 exploratory efficacy endpoints, including clinical symptom improvement, mortality rate, days of oxygen therapy, hospitalization days, and viral negativity.
The advisory committee judged that the submitted early Phase 2 clinical trial results only presented exploratory efficacy evaluation results as originally planned and did not demonstrate proven treatment efficacy.
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 grant approval conditional on Phase 3 clinical trials. The committee recommended submitting additional clinical trial results that can confirm treatment efficacy for approval review.
Adverse reactions occurred in 21 patients (45.65%) in the overall test group 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 group. Two deaths were reported as unrelated to the drug, and one death's relationship to the drug was unable to be assessed. Infusion-related adverse reactions were fever and erythema, all mild.
Adverse reactions of interest such as thrombosis, nephropathy, and renal dysfunction, which are reported in immunoglobulin products like Zicoviddic Injection, were not reported in either the test or control groups.
The advisory committee noted that although 3 deaths occurred in the test group, considering patients' underlying diseases, COVID-19 severity, and the small number of subjects, it is difficult to draw clear conclusions on safety. They emphasized the need for careful monitoring of adverse reactions in subsequent clinical trials.
The Ministry of Food and Drug Safety stated, "Following the results of this advisory committee meeting, the next step in the triple advisory process for COVID-19 therapeutics and vaccines, the Central Pharmaceutical Affairs Deliberation Committee meeting, will not be held. We plan to support the thorough design of any future follow-up clinical trials for Zicoviddic Injection."
GC Green Cross: "We will not rush to immediate tasks for product approval... Future plans to be discussed with health authorities"
On the same day, GC Green Cross expressed regret in a statement but conveyed their intention not to proceed with follow-up clinical trials.
GC Green Cross said, "It is true that the clinical data for Zicoviddic have limitations when viewed by general pharmaceutical development standards as confirmatory results. However, considering the significant indicators suggesting Zicoviddic's efficacy in certain patient groups and the National Institute of Infectious Diseases' research confirming potential efficacy against COVID-19 variants, our view is that increasing drug accessibility through product approval is a valid approach in a pandemic emergency."
They added, "Plasma treatments have public value as a 'first line of defense' during outbreaks of new infectious diseases, which is the significance of their development. Therefore, if the Ministry of Food and Drug Safety's recommendation implies the sunset of the temporary role of plasma treatments, we will not rush to immediate tasks for product approval."
They continued, "We believe it is our responsibility as a pharmaceutical company in a health emergency to explore ways for this drug to be used more efficiently in medical settings. We will closely discuss future plans with health authorities and transparently communicate the results."
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