Cellivery's 'iCP-NI' Primate COVID-19 Treatment Efficacy Evaluation Test Progressing Smoothly

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 27th that the second efficacy test of iCP-NI, a new drug under development for the treatment of coronavirus disease 2019 (COVID-19), is progressing smoothly in collaboration with Southern Research, a U.S.-based Contract Research Organization (CRO).

Cellivery has signed a three-phase contract with Southern Research to evaluate the efficacy of COVID-19 treatment. Currently, the cytokine storm-suppressing drug for severe sepsis, iCP-NI, is being evaluated for its therapeutic effects on acute pneumonia and severe sepsis caused by COVID-19.

A Cellivery official stated, “In the preliminary first test conducted by infecting African green monkeys with the COVID-19 virus, severe COVID-19 symptoms were observed. Not only external observations such as fever and irregular breathing but also virus replication, cell destruction, and tissue damage?all major aspects of COVID-19 progression?matched the symptoms seen in humans.”

Based on these results, Cellivery is currently conducting the second efficacy test of iCP-NI. In this test, two virus doses will be used to induce the COVID-19 monkey infection model: the highest virus dose reported so far and the highest physically administrable dose. Additionally, iCP-NI, an anti-inflammatory agent that suppresses cytokine storms, will be administered at the highest dose 24 hours after virus infection, when extracellular virus release and cytokine levels sharply increase.

The specific test design follows the recommendations of the Southern Research Institutional Review Board (IRB) for animal experiments, administering the drug twice daily via continuous intravenous infusion for 30 minutes each time. The study is divided into two groups: one group will be dissected on day 5 after 4 days of administration, and the other group will be dissected and analyzed on day 10, three days after completing 7 days of administration. A total of 16 monkeys will be used in this test, divided into iCP-NI treatment and control groups, two virus dose groups, and two administration period groups, resulting in eight experimental groups in total.

Cellivery plans to finalize the administration protocol and conditions for maximum efficacy of iCP-NI based on the results of this second test, and then promptly complete the large-scale third-phase efficacy evaluation using 24 to 40 monkeys. Furthermore, combining the safety evaluation data currently being conducted on rodents and primates at Kobangse, Cellivery intends to apply to the U.S. FDA for clinical trials and treatment use authorization within the shortest possible timeframe.

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