[서울=뉴스핌] Reporter Park Da-young = Daewoong Pharmaceutical’s chronic pancreatitis treatment’Hoystar’, which is being developed as a treatment for the novel coronavirus infection (Corona 19), did not meet the main evaluation parameters in phase 2a clinical trials. In response, the company announced that it has confirmed the possibility as a treatment for Corona 19.
Daewoong Pharmaceutical has released phase 2a clinical top-line data (some key indicators that are released before the final clinical results are announced) on the effect of COVID-19 treatment.
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| Daewoong Pharmaceutical’s exterior. [사진=대웅제약] |
Daewoong Pharmaceutical conducted phase 2a clinical trials in 89 mild or asymptomatic patients with Corona 19 in a placebo (fake drug) control, randomization, and double-blind method. A total of 81 patients excluding dropouts were compared and analyzed for clinical efficacy and safety.
An official of Daewoong Pharmaceutical explained, “The time taken until the virus negative, the main evaluation variable, was not statistically significant.” The official said, “However, the rate at which the virus is removed tends to be faster in the Hoystar group than in the placebo group.”
It is explained that Hoystar tablet does not directly kill the virus, but acts as a mechanism to prevent entry into the virus cell.
According to Daewoong Pharmaceutical, as a result of analysis of the ordinal scale and the NEWS score, which evaluates the time taken to improve the patient’s clinical symptoms, it was found that recovery tended to be faster in the Hoystar group. For symptom improvement, detailed analysis will be conducted.
This announcement is a top-line result, not analysis of all figures in the clinical trial. The company plans to officially publish the final results in an academic journal through further analysis.
Seung-ho Jeon, president of Daewoong Pharmaceutical said, “As a result of this phase 2a trial, the belief that self-treatment can be made possible by taking Hoystar tablets was confirmed in this clinical trial following the retrospective analysis results.” As it is finished, we will quickly draw the same results in large-scale patients and secure the results of phase 3 clinical trials in the first half of next year 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 to merge the phase 2 clinical trial of’Hoy Star Tablet’, which is being developed as a treatment for COVID-19, into phase 2 and 3 clinical trials. It is a situation that has begun.