▲ Cell Materapeutics CI
Cella Therapeutics (hereinafter Cella) announced on the 2nd that it has submitted an application for approval for a phase 3 clinical trial for a candidate drug for a new coronavirus infection (Corona 19) to the French Ministry of Food and Drug Safety (ANSM).
Celma is planning a global phase 3 clinical trial for domestic and European countries, and accordingly, it applied for a phase 3 clinical trial to the Korean Food and Drug Administration (KFDA) in October of last year and then to the French Food and Drug Administration.
Many of the existing COVID-19 treatment candidates are direct antiviral drugs, and the efficacy of the substance has not yet been verified, and there is no effective response to continued viral mutation.
Cella’s candidate material, which can expect a more fundamental and efficient antiviral effect that strengthens the immune system through regulation of interferon (IFN) in the human body during virus invasion, is attracting a lot of attention from related industries. Through a number of clinical trials recently, it has been found that the amount and activity of IFN, a substance that modulates the immune system, is associated with exacerbation of corona19 virus infection.
Cellma’s therapeutic candidates are already approved for sale overseas, and have been used for viral infections such as HIV and HCV for a long time, and the safety and antiviral efficacy of the drug have already been proven.
In addition, Cella confirmed the excellent anti-coronavirus efficacy of the drug in an experiment on cells infected with the Corona 19 virus, which was conducted by itself. Based on these evidences, Celma plans to conduct a clinically confirmed phase 3 clinical trial to evaluate the efficacy and safety of patients with COVID-19 virus infection.
This phase 3 clinical trial is a global clinical trial for moderate corona19 patients from Asian and Caucasian such as Korea and France. The study plan includes contents such as multicenter, randomization, parallelism, operator blinding, and placebo control. Cella plans to complete the global clinical phase 3 clinical trial for the drug candidate by the second quarter of this year and then launch the product immediately after applying for a new drug (NDA).
An official who participated in Celma’s clinical trial plan said, “Since this clinical trial includes subjects of different races, it will be a very suitable test to confirm the therapeutic efficacy of the widespread pandemic of Corona 19 virus infection regardless of race. Will” he explained.
Cella Chairman Yoon Byung-hak said, “Our corona treatment candidates are substances that have already been proven to be safe, and this clinical trial in moderate patients will significantly lower the probability of progressing to severe symptoms through recovery of symptoms in patients in the early and mid-stage infections. He said, “We will gather the company’s capabilities to solve the corona pandemic as soon as possible.”
Meanwhile, Celma has signed contracts with OPIS, a European clinical trial CRO company, and Korea Institute of Medicine for this global phase 3 clinical trial.