Economic Observer Network reporter Wang XinningOn April 6, Kintor Pharmaceutical-B (09939.HK) announced its general Key data results of the Phase III clinical trial of crudamide in the treatment of patients with mild to moderate COVID-19. Driven by this news, the stock soared 106.37% that day to close at HK$28.85 per share.
On the evening of December 27, 2021, Kintor announced that the interim analysis of the Phase III clinical trial did not reach statistical significance, and plans to continue recruiting only High-risk Covid-19 patients with underlying diseases and/or no Covid-19 vaccination history. The day after the announcement, its stock price plummeted 70.35%.
The Phase III clinical trial of proclutamide in the treatment of mild-to-moderate non-hospitalized patients with COVID-19 is a double-blind, placebo-controlled, randomized, global multicenter registration clinical trial. According to the announcement of Kintor Pharmaceuticals on April 6, the first subject of the trial was enrolled from April 24, 2021, and the enrollment of 733 subjects worldwide was completed on December 24, 2021. In the test, the subjects in the prokalutamide group were given oral prokalutamide 200 mg a day, and the treatment cycle was continuous administration for 14 days.
The data showed that N=730 in all subjects randomized and taking the drug for at least 1 day), the number of hospitalization events in the control group and the proclutamide group were 8 Cases (1 death) and 4 cases (no deaths), the corresponding protection rate was 50% (all subjects were hospitalized due to the new crown); among subjects who completed taking the drug for more than 1 day (N=721), the control group The number of hospitalization events in the prokalutamide group was 7 (1 death) and 2 (no death), respectively, with a corresponding protection rate of 71%; among subjects who completed medication for more than 7 days (N=693) , the number of hospitalization events in the control group and the proclutamide group were 6 (1 death) and 0 (p﹤0.02), respectively, and the corresponding protection rate was 100%.
Korean Pharmaceutical issued a document on its WeChat public account on the 6th, saying that Chairman Tong Youzhi said, “These data not only rigorously prove that proclutamide is in the new crown population (mainly affected by Delta) and Omicron variant strain infection), effectively reducing the hospitalization/mortality rate of patients, especially for all patients who took the drug for more than 7 days, and for middle-aged and elderly patients with high risk factors, the protection rate of 100% was statistically Significant.”
Kintor also believes that proclutamide can effectively reduce hospitalization rates and mortality, significantly and continuously reduce the novel coronavirus load, and improve novel coronavirus-related symptoms.
In terms of safety, during the entire trial, the incidence of adverse events was 7.9% in the control group and 9.6% in the proluamide group, most of which were mild, and no serious adverse events were found event.
The release of the Phase III clinical results has reversed the market’s perception. After the opening, Kintor Pharma once increased by nearly 200%, and as of the close, the increase is still more than 100%, and the stock price has doubled in a single day. .
Economic Observation Network reporters tried to ask the company about the process of developing proclutamide for the treatment of COVID-19 and becoming a marketed drug in the future, but its registration phone number is empty, and the official website staff The phone call was also not connected.
Public information shows that Prokalutamide is one of the drugs under research by Kintor, which was originally used for the treatment of mCRPC (metastatic castration-resistant prostate cancer). Molecular AR antagonists. After the outbreak of the new crown epidemic in 2020, the research and development team of Kintor Pharmaceutical noticed that the disease progression and hospitalization death of male patients were more serious than that of female patients, so they began to analyze the mechanism behind this difference.
As for the mechanism of action of the drug in the treatment of new coronary pneumonia, Kintor Pharmaceuticals stated that in the early stage of new coronary infection (mild and moderate patients), proclutamide reduces the invasion of the new coronavirus by reducing the The expression levels of two key proteins (ACE2 and TMPRSS2) of host cells that prevent the new coronavirus from invading host cells.
On February 10, 2022, the Phase III clinical trial of proclutamide in the treatment of non-hospitalized patients with mild to moderate illness with COVID-19 completed the enrollment and administration of the first subjects in China. Tong Youzhi said that the company will actively push forward the application for emergency drug EUA licenses from national drug regulatory agencies in China, the United States and other countries and regions.