Cannot secure statistical significance of main evaluation variable
Virus removal is faster than placebo
Daewoong Pharmaceutical(167,000 ↓29.98%)On the 23rd, announced the major (top-line) results of Phase 2a clinical trials on the treatment effect of Hoystar tablets for novel coronavirus infection (Corona 19). It is explained that the statistical significance of the main endpoint was not secured, but the possibility was confirmed in terms of virus removal rate compared to the placebo group.
Phase 2a was conducted in a placebo-controlled, randomized, double-blind method for a total of 89 confirmed mild or asymptomatic patients hospitalized for Corona 19. 81 patients (41 in the Hoystar group and 40 in the placebo group) were compared, excluding the dropouts.
Daewoong Pharmaceutical said, “The time taken to negative virus (viral death), the main evaluation variable, was not statistically significant, but the rate at which the virus was removed tended to be faster in the Hoystar group than in the placebo group.” The company reported that it is a remarkable result considering that the mechanism of action of Hoystar is not that it directly kills the virus, but that it blocks the entry of the virus into the cell (TMPRSS2 inhibitor).
As a result of the analysis of the ordered scale and the NEWS score, the time it took for the patient’s clinical symptoms to improve, the Hoystar group showed a tendency to recover faster.
The researchers who participated in the clinical trial said, “As a result of Phase 2a, Hoystar tablet is expected to be effective in improving patients’ symptoms and eliminating viruses.” He said.
Daewoong Pharmaceutical will publish the final results in an academic journal through further analysis and in-depth consideration with experts.
Seung-ho Jeon, president of Daewoong Pharmaceutical, said, “We have completed preparations for phase 2b and 3 clinical trials,” and said, “We have obtained the same results in large-scale patients and secured the results of phase 3 clinical in the first half of next year, so that Hoystar can establish itself as a global COVID-19 treatment. I will.”
On the 17th, Daewoong Pharmaceutical received approval from the Ministry of Food and Drug Safety to merge phase 2 clinical trials of Hoystar tablets being developed as a treatment for Corona 19 into phases 2 and 3.
In addition to Hoystar, Daewoong Pharmaceutical plans to finish phase 1 clinical trials of niclosamide injections being developed as a treatment for Corona 19 in India and other countries, and prepare for phase 2 clinical trials in multiple countries.
Reporter Minsoo Han [email protected]
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