Cellivery "New Drug for Severe Sepsis Treatment... Begins Primate Toxicity Testing for US FDA Clinical Trials"

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 1st that it has signed a toxicology testing contract with Covance, a contract research organization (CRO) specializing in safety evaluation, to conduct toxicology tests of the cytokine storm suppressing severe sepsis treatment new drug iCP-NI in large and small animals.

iCP-NI is an anti-inflammatory treatment new drug that treats acute pneumonia and severe sepsis caused by cytokine storms resulting from infections such as the novel coronavirus disease (COVID-19).

The toxicology evaluation test will be conducted on 50 adult Philippine monkeys and 300 rats, aiming to prove the safety of iCP-NI, which is a final essential requirement for clinical trials by the US FDA and Korean KFDA. The total experimental cost is 2.9 billion KRW. It is also being conducted simultaneously with the COVID-19 efficacy evaluation test at Southern Research, which started on the 27th of last month.

The iCP-NI efficacy evaluation is a test administering the cytokine storm suppressor iCP-NI to an acute pneumonia model where inflammatory cytokines rapidly increase in the lung mucosa and blood due to direct COVID-19 infection in 34 primates. The total experimental cost was 1.7 billion KRW. According to the company, a total of 8 billion KRW was required for the COVID-19 related severe sepsis treatment new drug iCP-NI project to enter clinical trials, including large-scale production of non-clinical and clinical samples and US FDA clinical consulting fees.

CEO Daewoong Cho explained, "The reason for conducting the safety evaluations such as toxicology, pharmacokinetics, and pharmacodynamics of iCP-NI at Covance and the COVID-19 therapeutic efficacy evaluation at Southern Research simultaneously is to conduct simultaneous fast-track clinical trials with the US FDA and Korean KFDA," adding, "This is based on the opinion of the FDA clinical consulting CRO that conducting all tests at a top-level contract research organization located in the US is very helpful."

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