Cellivery Confirms Poland as European Clinical Trial Country for COVID-19 Immune Therapy iCP-NI

[Asia Economy Reporter Hyunseok Yoo] Cellivery, a company developing COVID-19 therapeutics, announced on the 9th that it has designated the countries for clinical trials conducted in Europe following the United States.

Since signing a contract with the European clinical trial contract research organization (CRO) Office on the 20th of last month, Cellivery has begun drafting the European clinical trial protocol (EMA IND) based on the non-clinical trial results already derived in the United States. On this day, Poland was confirmed as the European clinical trial country.

The country selection was based on the characteristics of the clinical development drug and the comprehensive European clinical database possessed by Office. This proprietary database includes patient incidence trends in various European countries, approval criteria and required time from government agencies, clinical trial base hospitals, and the participation tendencies of clinical trial investigators. The selection method involves simulation to choose countries with high clinical environment quality, success probability, and fast progress speed.

Poland is one of the countries in Europe where clinical trial-related approvals are processed quickly. It is considered the most advantageous for the approval and progress of clinical trial plans to develop iCP-NI as a COVID-19 therapeutic. Additionally, since Office is stationed there and is already conducting several new drug clinical trials, the hospitals and overall infrastructure for conducting clinical trials are well understood. The company explained that the target country was decided based on the judgment that the clinical trial could be completed early without unexpected delays or serious issues.

With the clinical trial country decided, the drafting of the European clinical trial protocol by Cellivery and Office is also nearing completion.

Jodaewoong, CEO of Cellivery, said, "Unlike the United States, Europe will proceed with clinical trial approval applications without a pre-IND meeting. The timing of clinical entry could be faster than in the U.S., so we expect it to be considerably quicker than the initially conservative schedule."

He added, "According to the European clinical synopsis drafted so far, it has been decided to conduct Phase 1 clinical trials simultaneously on both COVID-19 infected and non-infected subjects, so safety and efficacy can be demonstrated early. Since clinical trials will be conducted almost simultaneously in the U.S. through Covance, we expect to derive sufficient early COVID-19 therapeutic efficacy results in Phase 1."

CEO Cho emphasized, "From Phase 2 clinical trials, clinical development will expand to the U.S., Europe (including Poland), and India. Through these global clinical trials, sufficient clinical data for COVID-19 treatment can be secured, which will be highly advantageous for obtaining emergency approval from the U.S. FDA’s Emergency Access Program (EAP) and compassionate use programs from the European Medicines Agency (EMA) in the future."