After Merck released positive clinical data, COVID-19 oral medicines became the focus of market attention. In addition to Merck, three other companies will release their Phase 3 clinical data on COVID-19 oral medicines in the fourth quarter, including pioneering pharmaceuticals from China.
<h2>Reduces the risk of hospitalization or death by 50%.</h2>
On Friday, October 1, EST, veteran pharmaceutical giant Merck took the lead in delivering good news that the oral anti-coronavirus experimental pill developed by partner Ridgeback Biotherapy could reduce the risk of hospitalization or death by 50%.
Merck said the midterm trial followed 775 adults with mild to moderate COVID-19. The trial results showed that within 5 days of the onset of COVID-19 symptoms, only 7.3% of patients taking the antiviral oral pill molnupiravir were hospitalized or died after 30 days, compared with 14.1% of patients taking a placebo.
Shadong said it is currently planning to submit an application for emergency use authorization to the FDA as soon as possible and will seek emergency use authorization from other health regulators around the world.
According to the relevant professional media collation, the data released this time: the hospitalization or mortality rate of the Molnupiravir treatment group was 7.3% (28/385), the hospitalization or mortality rate of the control group was 14.1% (53/377), and the hospitalization or mortality rate of Molnupiravir was reduced by 50%, and the p-value was 0.0012. In terms of mortality, there were no deaths in the treatment group and 8 deaths in the control group.
As a small molecule antiviral drug, the clinical efficacy of Molnupiravir can be described as very significant, although the reduction in hospitalization/mortality is still lower than that of the neutralizing antibody, but the absence of death in the treatment group also indicates that the treatment effect is very significant. Small molecule drugs also have significant cost advantages, and the scale of production is easy to scale up.
By the close, Dow constituent Merck (MRK) was up more than 12 percent intraday, closing at $81.4, its highest intraday gain since 2009. In contrast, COVID-19 vaccine developers have collectively declined, with CureVac closing down more than 14.7%, Novavax down 12.4%, Modena down about 11.4%, Vaxart down about 9.7%, BioNTech down about 6.7%, and INO down more than 6.4%.
<h2>In the fourth quarter, there were 3 Phase 3 clinical blindfolding</h2>
Merck's eye-catching data has made THE NEW CROWN oral drug the focus of the market.
Wall Street Insight Institute previously showed that in the fourth quarter, three other companies around the world will release their phase 3 clinical data on the new crown oral drug, including the AR antagonist pkrutamine (phase III) in the pioneering pharmaceutical industry, Roche's RNA polymerase inhibitor AT-527 (phase III), and Pfizer's 3CL protease inhibitor PF-07321332 (phase III). Among them, the pioneering pharmaceutical industry from China is the most concerned by Chinese investors.
Pkrutamine is an AR (androgen receptor androgenreceptor) antagonist developed in the pioneering pharmaceutical industry. According to pioneering pharmaceutical research, pkrutamine inhibits androgen receptor function, downregulates the expression of ACE2 and TMPRSS2 from the transcriptional level, thereby blocking SARS-CoV-2 from the host cell.
Pioneering Pharmaceuticals previously announced at noon on September 1 that the company has obtained approval from the State Drug Administration to conduct two Phase 3 clinical trials in China for mild and moderately ill and hospitalized patients with severe diseases that are intended to be used to treat novel coronavirus pneumonia. It is also the first COVID-19 oral drug to be conducted in phase 3 clinical trials in Chinese mainland.
The Wall Street Insight Institute believes that the pioneering pkrutamine has therapeutic potential in the new crown mild to severe disease. In addition, the efficacy of pkrutamine in severely ill patients may be related to mechanisms that have not yet been discovered, such as the effect on inflammatory storms.
It should be noted that from the perspective of small-scale early data, several oral drugs generally have obvious effects on patients with mild and moderate disease who do not need to be hospitalized, can block viral infection or replication, quickly reduce the viral load, and greatly reduce the possibility of patients' symptoms turning serious.
However, for hospitalized patients with severe disease, most of the drugs that inhibit the principle of viral replication are not particularly effective, because the severe patients themselves have other symptoms such as cytokine storms, and it is difficult to reverse these symptoms by simply inhibiting the virus.
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