[이코노믹리뷰=황진중 기자] The main evaluation variable was not satisfied in phase 2a of’Hoy Star Tablet’ being developed by Daewoong Pharmaceutical (069620) as a treatment for Corona 19.
Daewoong Pharmaceutical announced on the 23rd that it has revealed the results of the Phase 2a clinical topline on the effect of’Hoy Star Tablet’ on the treatment of Corona 19.
According to Daewoong Pharmaceutical, this clinical trial is conducted in a placebo-controlled, randomized, double-blind method for a total of 89 confirmed mild or asymptomatic patients hospitalized with COVID-19, including Professor Myung-don Oh of Seoul National University, who is the chief researcher. did. In clinical trials, a total of 81 patients (41 patients in the Hoystar group, 41 patients in the Hoystar group, 40 patients in the placebo group, and the average age 43 years) were analyzed for clinical efficacy and safety.
Daewoong Pharmaceutical said, “The time taken until the virus negative, 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.” “It is not a drug, but a remarkable result considering that it is a mechanism that blocks the entry of the virus into the cell (TMPRSS2 inhibitor).”
An official of Daewoong Pharmaceutical said, “The time taken to improve the clinical symptoms of patients, as a result of analysis of the ordinal scale and the NEWS score, showed a tendency to recover more quickly in the Hoystar group.” As the clinical significance is great, detailed analysis will be conducted.”
Researchers participating in the clinical trial said, “As a result of this phase 2a clinical trial, Hoystar tablets are expected to be effective in improving patients’ symptoms and removing viruses, and it is meaningful that they confirmed the possibility of developing a therapeutic agent that meets the purpose of the therapeutic exploration trial. He emphasized that “therefore, we plan to conduct a large-scale phase 2b/3 clinical trial to finally confirm the treatment effect.”
This is the top line result. Since Daewoong Pharmaceutical has not yet analyzed all the figures, the final results will be officially published in the journal through further analysis and in-depth discussion with clinical participants and experts in infectious medicine.
Seung-ho Jeon, president of Daewoong Pharmaceutical, said, “The belief that self-treatment can be made possible by taking Hoystar tablets from the results of this phase 2a trial was confirmed in this clinical trial following the retrospective analysis results.” “Already prepare for phase 2b/3 clinical trials. He said, “Because of the situation, 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.
Daewoong Pharmaceutical is planning to finish phase 1 clinical trials of niclosamide injections, which are being developed as a treatment for Corona 19 other than Hoystar, in India, and prepare for multinational phase 2 clinical trials. Previously, Daewoong Pharmaceutical proved its antiviral efficacy through a viral gene amplification test in a hamster effect model recommended by the National Institute of Health (NIH), and its anti-inflammatory efficacy was confirmed in the lung tissue pathology test results. Daewoong Pharmaceutical expects to shorten the treatment period and improve the survival rate of patients with Corona 19 based on the results of the two tests.