Cellivery Completes European Clinical Application for COVID-19 Immune Therapy iCP-NI

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 7th that it has registered the clinical trial of the COVID-19 treatment iCP-NI in Europe in the European Union (EU) clinical trial database.

Along with this, it disclosed on the same day that it completed the Clinical Trial Application (CTA) on September 6 local time to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for Phase 1 clinical trial titled "Dose Escalation and Safety Evaluation of iCP-NI in Healthy Volunteers."

The COVID-19 treatment iCP-NI under clinical development by Cellivery is an immunotherapy for infectious diseases that can cause death due to permanent lung damage and cytokine storm caused by viral infection. Development began in February last year.

iCP-NI has accumulated efficacy data in various infectious disease models, starting with efficacy evaluation in non-human primates infected with COVID-19, and has been recognized for its therapeutic efficacy. Safety was secured by verifying non-toxicity at pharmacological doses through toxicity evaluations in rodents and non-human primates conducted by Covance in the U.S., a GLP-level global non-clinical safety evaluation institution.

In this clinical trial, iCP-NI will be administered to 48 clinical trial volunteers (12 placebo group, 36 drug administration group), and human safety will be evaluated for 7 days. Pharmacokinetics (PK), which determines the absorption, distribution, metabolism, and elimination of iCP-NI in the body, will be assessed.

The clinical trial in Europe will also be conducted at one hospital. The purpose is to evaluate the safety and pharmacokinetic characteristics of iCP-NI and to determine the dose for Phase 2 clinical trials. The detailed protocol for the clinical trial will be registered on the European Union clinical trial site simultaneously with the start of the clinical trial. It will also be posted on the global clinical trial site operated by the U.S. National Institutes of Health (NIH).

The reason for conducting Phase 1 clinical trials only for safety evaluation in healthy individuals is a strategy to complete early in the shortest time and quickly enter Phase 2 clinical trials targeting COVID-19 infected patients to apply for emergency use authorization and treatment use authorization.

To this end, preparations for entering Phase 2 will be conducted concurrently while Phase 1 is underway. The goal is to proceed to Phase 2 immediately after the completion of Phase 1.

A Cellivery official said, "Through this clinical trial, Cellivery has become a company that possesses its own clinical pipeline and has established the experience and system for continuous clinical development," adding, "We were able to take a step forward as a new drug development company by laying the foundation for sustainable growth in the future."

The official emphasized, "Based on the clinical trial of iCP-NI, we were able to officially present and gain recognition of the value of Cellivery’s platform technology, Therapeutic Substance Delivery Technology (TSDT), to global pharmaceutical companies once again," and "This has increased opportunities to proceed with smoother joint development and licensing-out (L/O) business."

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