Cellivery Signs Clinical Approval Contract with Covance... "Fastest Entry into US Clinical Trials"

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 16th that it has signed a clinical trial authorization contract with global clinical research organization Covance to enter clinical trials with the U.S. FDA for the severe sepsis treatment new drug 'iCP-NI,' which suppresses cytokine storm, and plans to enter U.S. FDA clinical trials in the shortest possible time.

iCP-NI is a mechanism-specific targeted anti-inflammatory new drug that can treat severe sepsis and septic shock caused by the 'cytokine storm' occurring in severe inflammatory conditions due to the invasion of pathogenic bacteria and viruses such as the novel coronavirus infection (COVID-19).

Covance is the world's only global top clinical trial organization capable of conducting both non-clinical and clinical trials. Through this contract, Covance will act on behalf of Cellivery for the entire process from comprehensive consultation on iCP-NI's pre-clinical trials, preparation of the International Council for Harmonisation (ICH) Common Technical Document for pharmaceuticals, actual preparation and submission of clinical trial applications to the U.S. FDA, to clinical approval.

Cellivery signed a clinical trial authorization contract with Covance, which is of the highest global standard, to enter clinical trials. Not only will the credibility of the data be guaranteed and strict management will be conducted to ensure compliance with international standards and FDA guidelines, but safety evaluations and clinical trial authorizations will be conducted by a single global company, enabling the actual clinical trial entry time to be shortened by several months or more. A company official stated, "Covance has extensive experience in clinical trial applications and progress," and emphasized, "It is based in the U.S., and through this contract, we expect to communicate with the U.S. FDA more quickly and efficiently."

Cellivery is mass-producing non-clinical and clinical samples domestically and overseas and conducting safety tests at Covance. Additionally, therapeutic efficacy tests against COVID-19 are being conducted simultaneously at Southern Research. They are securing safety evaluation results such as toxicity, pharmacokinetics, and pharmacodynamics, as well as therapeutic efficacy evaluation results against COVID-19.

The ongoing safety and efficacy evaluations can be conducted with KGMP-grade iCP-NI, and clinical trials to be conducted in Korea can also use KGMP-grade samples. However, clinical trials conducted in the U.S. require iCP-NI produced at cGMP grade. A company official said, "If COVID-19 has not ended by the time U.S. clinical trials begin, it is highly likely that the drug will be administered to patients simultaneously with the clinical trial, so large-scale production capable of supplying many patients is necessary," adding, "Although the production cost will reach hundreds of billions of won, it is predicted that by that time, joint development or licensing deals with global partners will be concluded, so cost will not be an issue." He continued, "Once all preparations necessary for clinical trial entry are completed through this U.S. FDA clinical trial authorization contract, clinical trials in Korea and the U.S. are scheduled to begin in the shortest time through Covance."

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