Cellivery Signs Clinical Advisory Contract for Severe Sepsis Treatment New Drug

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 29th that it has signed a clinical advisory contract with Kyung Hee Medical Center to facilitate early clinical entry of the novel drug iCP-NI for severe sepsis treatment.

According to the contract with Kyung Hee Medical Center, Cellivery aims to enter clinical trials within this year. A company representative stated, "Through regular conferences on the novel drug iCP-NI for severe sepsis treatment, we plan to achieve early clinical entry by consulting with clinical advisory professors on key clinical trial decisions such as non-clinical efficacy and safety evaluations, clinical diseases, patient groups, and clinical protocols."

Sepsis occurs due to infections caused by bacteria such as Salmonella or Vibrio, or viral pathogens like coronavirus and influenza virus. Additionally, when the body's defense system is excessively activated due to severe trauma, a 'cytokine storm' is triggered, causing severe systemic inflammatory responses that can lead to death. The fatality rate is 30% (approximately 40% domestically), making it the third leading cause of death worldwide after cancer and heart disease, according to the company.

The cell-penetrating peptide therapeutic iCP-NI is an anti-sepsis agent that inhibits cytokine expression. Daewoong Cho, CEO of Cellivery, said, "In an acute severe hepatitis animal model caused by fatal pathogenic bacterial infection where 100% of the control group died, the iCP-NI treated group showed a 100% survival rate." He added, "In a peritonitis model caused by bacterial infection, which is the animal model most similar to human sepsis, it demonstrated over 80% survival rate." He continued, "We have already demonstrated a groundbreaking anti-inflammatory effect by reducing pro-inflammatory cytokines in the blood and increasing anti-inflammatory cytokines," and said, "Based on the drug’s definite mechanism of action, we expect to achieve good results in clinical trials targeting sepsis patients."

He emphasized, "Currently, process development for large-scale production of non-clinical and clinical samples is complete at a peptide synthesis specialized contract manufacturing organization (CMO), so large-scale sample production will be carried out soon." He added, "Using these samples, we plan to conduct safety tests in the shortest possible time and proceed with clinical trials on patients with severe sepsis."