Merck & Co Inc (NYSE: MRK) has claimed that its investigational oral drug for the treatment of COVID-19, Molnupiravir, has demonstrated the ability to decrease hospitalization or mortality in individuals with severe illness by around 50%.
With Ridgeback Biotherapeutics on board as a co-developer, Merck intends to move quickly to get emergency use permission for the tablet in the US, and also send out applications to regulatory authorities across Europe and other major regulators across the globe. The FDA and an independent body recommended the suspension of the ongoing phase 3 study, which was initially scheduled to end in November, of the drug because of the positive findings. The stock closed Friday’s trading at $81.40, reflecting a gain of $6.29 or 8.37% from the prior close.
The drug Molnupiravir was developed by the Darmstadt, Germany-based Merck in partnership with Ridgeback Biotherapeutics LP for treating COVID-19 infected people who are not hospitalized, had relevant symptoms for a maximum of five days, and face a risk of serious illness. During the clinical trial involving volunteers across the globe, Molnupiravir was administered once in 12 hours for five days.
An intermediate review of late-stage studies found that Molnupiravir decreased the risk of hospitalization or mortality by 50% compared to the placebo group. To be more specific, a predefined interim review of 775 participants in Merck’s trial revealed that 7.3% of those administered with Molnupiravir were either hospitalized or deceased in 29 days after therapy, opposed to 14.1% of those treated with placebo. Notably, no fatalities were reported among individuals administered with Molnupiravir, while the death count was eight with respect to those treated with placebo. The results promise to provide physicians with yet another effective virus-fighting therapy.
According to the media release, Merck had already enrolled 90% of 1,550 volunteers for the clinical study. Patients who were previously administered with a placebo will be given the option to begin receiving Molnupiravir, according to Merck CEO Robert Davis.
Earlier last week, Merck published further data (based on viral sequencing) from an early-stage clinical study, which showed that Molnupiravir seemed to be effective against many coronavirus strains, including the very infectious Delta variant. Furthermore, according to Merck, individuals administered with Molnupiravir and placebo had comparable rates of adverse reactions. However, the company refrained from providing more information on the health complications.
According to Merck’s research, Molnupiravir does not cause genetic alterations in human cells. However, males who participate in Merck’s clinical trials must refrain from heterosexual relations or pledge to utilize contraceptives throughout the trial duration. Also, women of reproductive age should avoid pregnancy by using contraceptives.
The company has also revealed its plan to produce 10 million drug courses by the end of 2021 and more in the years ahead. In this regard, the firm has agreed with the United States government to deliver 1.70 million drug courses. The company has priced Molnupiravir at $700 per course.
The CEO stated that the company has comparable deals with several countries across the globe and is also in discussions with others. The firm said that it intends to adopt a layered pricing strategy depending on the income levels of each nation. With an agreement in place, Merck will also provide licenses to numerous Indian generic drug makers to provide the therapy in several underdeveloped and developing nations.
Additionally, Molnupiravir is being evaluated in a Phase 3 study for its ability to limit coronavirus transmission in individuals who have been exposed to the coronavirus. Officials from Merck have said that they are unsure about the time required for the FDA to complete the evaluation of the drug. In case of approval by regulatory authorities, Molnupiravir, which induces flaws in the genetic coding of the virus, will be the initial oral preventive treatment for COVID-19. Davis believes that the developments will have an impact on the conversation around the control of COVID-19 infections.
The positive news about oral COVD-19 drug Molnupiravir is expected to keep the stock bullish in the short term.
The historical price chart indicates that the stock has broken the range (71-79) in which it was trading for the past three months. The MACD indicator is also rising in the positive zone. Therefore, we are anticipating the stock to remain in an uptrend in the short term.
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