Cellivery Confirms Synopsis for US Clinical Trial of COVID-19 Immune Therapy

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 12th that the clinical synopsis for the US clinical trial has been completed.

Since May of last year, Cellivery has been outsourcing the entire process of clinical development for the immune therapeutic iCP-NI's COVID-19 clinical trial to Covance, a US non-clinical and clinical contract research organization. In less than a year, the new drug's clinical development has completed the clinical synopsis, including efficacy and safety evaluation tests on primates. According to the company, this enables a swift transition to the next stage of initiating clinical trials across the United States.

The clinical synopsis is a document based on all accumulated drug analysis results, including pharmacokinetics and pharmacodynamics, as well as toxicity and efficacy test results on small and large animals. It includes all plans to be carried out during the clinical trial, such as scheduling, subject selection, administration methods, result analysis methods, and response manuals for various situations. The company explained that this is the most important material forming the foundation of clinical trial reviews conducted by the US Food and Drug Administration (FDA).

On June 11, the clinical synopsis for the COVID-19 therapeutic iCP-NI's clinical development in Europe was also completed, and the company is currently preparing to file an Investigational New Drug (IND) application with the European Medicines Agency (EMA). With the completion of the US clinical synopsis, clinical trials are now forthcoming in both Europe and the United States.

Jodaewoong, CEO of Cellivery, stated, "Our plan was to start clinical trials first in the US and then sequentially expand to third countries such as Europe. However, due to external factors including local circumstances in the US and our partners, the scheduled development timeline was delayed, resulting in the European clinical synopsis being completed first. Now that the US clinical synopsis is also completed, we are preparing the Pre-IND Meeting package to be submitted to the US FDA based on this."