(Businesshala) – An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for people who are at risk of contracting severe COVID-19, according to data Experts have hailed it as a potential breakthrough in treating the virus. .
If it gets authorization, molnupiravir, which is designed to introduce errors in the virus’s genetic code, would be the first oral antiviral drug for COVID-19.
Merck and partner Ridgeback Biotherapeutics said they plan to seek US emergency use authorization for the pill as soon as possible and make regulatory applications around the world.
“An oral antiviral to the extent that it could affect the risk of hospitalization would be game-changing,” said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.
Current treatment options include Gilead Sciences Inc.’s infused antiviral remdesivir and the generic steroid dexamethasone, both of which are typically given only once a patient is hospitalized.
“This is going to change the conversation about how to manage COVID-19,” Merck chief executive Robert Davis told Businesshala.
Existing treatments are “cumbersome and logistically challenging to administer. A simple oral tablet would do the opposite,” Adalja said.
The results of the Phase III trial, which sent Merck shares up more than 9%, were so strong that the study was being halted early on the recommendation of external monitors.
Shares of Atea Pharmaceuticals Inc., which is developing a similar COVID-19 treatment, were up more than 21% on the news.
Here shares of COVID-19 vaccine makers Moderna Inc were down more than 10%, while Pfizer was down less than 1%.
Jefferies analyst Michael Yee said investors believe “people will be less afraid of COVID and less willing to vaccinate if there is a simple pill that can treat COVID.”
Pfizer and Swiss drugmaker Roche Holding AG are also racing here to develop an easily administered antiviral pill for COVID-19. For now, only antibody cocktails that have to be given intravenously are approved for non-hospitalized patients.
White House COVID-19 response coordinator Jeff Ziants said Friday that mollupiravir “is a potential additional tool … 19.”
A planned interim analysis of 775 patients in the Merck study looked at hospitalization or death among those at increased risk of serious illness. It found that 7.3% of those given molanupiravir twice a day for five days were hospitalized and none died for 29 days after treatment. This is compared to a hospitalization rate of 14.1% for placebo patients. There were also eight deaths in the placebo group.
Ridgeback CEO Wendy Holman said in a statement, “At-home antiviral treatments are critically needed to keep people with COVID-19 out of hospital.”
‘A big advance’
Scientists welcomed a potential new treatment to help prevent serious illness from the virus, which has killed nearly 5 million people worldwide, 700,000 of whom are in the United States.
“A safe, affordable and effective oral antiviral would be a major advance in the fight against COVID,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford.
The study enrolled patients with laboratory-confirmed mild to moderate COVID-19 who did not have symptoms for more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.
A similar class of drugs as mollupiravir have been linked to birth defects in animal studies. Merck says similar studies of molnupiravir — longer and at higher doses than those used in humans — indicate that the drug does not affect mammalian DNA.
Merck said the viral sequencing performed so far shows that molnupiravir is effective against all forms of the coronavirus, including the highly transmissible delta, which has recently prompted an increase in hospitalizations and deaths around the world.
It said the rate of adverse events was similar for both mollupiravir and placebo patients, but did not provide details.
Merck has said that the data shows that molnupiravir is not able to induce genetic changes in human cells, but that the men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. The study required women of child-bearing age to become pregnant and also to use birth control.
The US drugmaker said it expects to have ready 10 million courses of treatment by the end of 2021.
The company has a contract with the US government to supply 1.7 million courses of mollupiravir at a cost of $700 per course.
Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on the country’s income criteria.
A US health official told Businesshala that the US government has the option of purchasing an additional 3.5 million treatment courses if needed. The official asked to remain anonymous because he was not authorized to comment publicly on the contract.
Merck has also agreed to license the drug to several India-based generic drug manufacturers, who will be able to supply the treatment to low- and middle-income countries.
Molnupiravir is also being studied in Phase III trials to prevent infection in people exposed to the coronavirus.
Merck officials said it was unclear how long the FDA review would take, although Dean Lee, the head of Merck’s research laboratories, said “they are going to try to work on it with full urgency.”