 / Provided by Daewoong Pharmaceutical |
After the final analysis with the clinical participants
Plan to announce official results through specialized academic journals
Daewoong Pharmaceutical (President Seung-ho Jeon) released the results of the Phase 2a clinical topline on the treatment effect of Hoy Star Tablet on the 23rd.
According to Daewoong Pharmaceutical, this clinical trial was conducted in a placebo-controlled, randomized, and double-blind method for a total of 89 mild or asymptomatic confirmed patients hospitalized for COVID-19 with the participation of Professor Myung-don Oh of Seoul National University and researchers from 13 institutions, who are the lead researcher Excluding dropouts, a total of 81 patients (41 patients in the Hoystar group, average age 55 years old / 40 patients in the placebo group, average age 43 years) were compared to analyze clinical efficacy and safety.
Daewoong Pharmaceutical said, “The time taken until the virus negative prevalence, which is the main evaluation variable, was not statistically significant, but the rate at which the virus was removed tended to be faster in the Hoista group than in the placebo group.” Hoystar’s mechanism of action directly kills the virus. This is a remarkable result considering it is a mechanism that prevents the entry of the virus into cells (TMPRSS2 inhibitor), not a drug that is to be ordered.
Moreover, as a result of the analysis of the ordinal scale and the NEWS score, the time taken to improve the patient’s clinical symptoms showed a tendency to recover faster in the Hoystar group, and the improvement result of the symptom scale was of great clinical significance. As much as that, detailed analysis will be conducted.
Meanwhile, the researchers who participated in the clinical trial said, “As a result of this phase 2a trial, Hoystar tablets are expected to be effective in improving patients’ symptoms and removing viruses, and confirming the possibility of developing a therapeutic agent that meets the purpose of the therapeutic exploration trial. It is significant,” he said, and said, “We plan to conduct a large-scale phase 2b/3 clinical trial in the future to confirm the treatment effect.”
The current results are top-line results, and since all figures have not been analyzed so far, the final results will be officially published in the journal through further analysis and in-depth consideration with clinical participants and experts in infectious medicine.
Seung-ho Jeon, president of Daewoong Pharmaceutical, said, “The belief that self-treatment can be possible by taking Hoystar tablets as a result of this phase 2a trial was confirmed in this clinical trial following the retrospective analysis results.” “Already prepare for phase 2b/3 clinical trials As it is completed, we will quickly draw the same results in large-scale patients and secure the results of phase 3 clinical trials within the first half of 2021 so that Hoystar can establish itself as a global COVID-19 treatment.”
On the other hand, Daewoong Pharmaceutical received approval from the Ministry of Food and Drug Safety on the 17th as a phase 2 clinical trial of Hoy Star Tablet, which is being developed as a treatment for COVID-19, as a phase 2/3 clinical trial. I have started.
Reporter Choi Jae-won, Cultural Journal 21