Merck's COVID-19 pill cuts risk of death, hospitalization by 50% in study

[New Reporter]

Merck's COVID-19 pill cuts risk of death, hospitalization by 50% in study

October 1, 2021

Oct 1 (Reuters) - Merck & Co Inc's (MRK.N) experimental oral drug for COVID-19, molnupiravir, reduced by around 50% the chance of hospitalization or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday.

Merck and partner Ridgeback Biotherapeutics plan to seek U.S. emergency use authorization for the pill as soon as possible, and to submit applications to regulatory agencies worldwide. Due to the positive results, the Phase 3 trial is being stopped early at the recommendation of outside monitors.

"This is going to change the dialogue around how to manage COVID-19," Robert Davis, Merck's chief executive officer, told Reuters.

If authorized, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

Rivals including Pfizer Inc (PFE.N) and Swiss pharmaceutical Roche Holding AG (ROG.S) are racing to develop an easy-to-administer antiviral pill for COVID-19 but so far, only antibody cocktails - which have to be given intravenously - are approved for treating non-hospitalized COVID-19 patients.

A planned interim analysis of 775 patients in Merck's study found that 7.3% of those given molnupiravir were either hospitalized or had died by 29 days after treatment, compared with 14.1% of placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths of placebo patients.

"Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback's CEO, said in a statement.

In the trial, which enrolled patients around the world, molnupiravir was taken every 12 hours for five days.

The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus, including highly transmissible Delta.

The company said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details of the side effects.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials have to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age cannot be pregnant and also have to use birth control.

Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more doses coming next year.

The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.

CEO Davis said Merck has similar agreements with other governments worldwide, and is in talks with more. The company said it plans to implement a tiered pricing approach based on country income criteria.

Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a Phase 3 trial for preventing coronavirus infection in people exposed to the virus.

Merck officials said it is unclear how long the FDA review of the drug will take.

"I believe that they are going to try to work with alacrity on this," said Dean Li, head of Merck's research labs.

[New Reporter]

Merck says experimental pill cuts worst effects of COVID-19

WASHINGTON (AP) — Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.

If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.

Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for severe disease due to health problems such as obesity, diabetes or heart disease.

Among patients taking molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those getting the dummy pill. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck. The results were released by the company and have not been peer reviewed. Merck said it plans to present them at a future medical meeting.

An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong. Company executives said they are in discussions with the Food and Drug Administration and plan submit the data for review in coming days.

“It exceeded what I thought the drug might be able to do in this clinical trial,” said Dr. Dean Li, vice president of Merck research. “When you see a 50% reduction in hospitalization or death that’s a substantial clinical impact.”

Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.

Earlier study results showed the drug did not benefit patients who were already hospitalized with severe disease.

The U.S. has approved one antiviral drug, remdesivir, specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus. But all the drugs have to given by IV or injection at hospitals or medical clinics, and supplies have been stretched by the latest surge of the delta variant.

Health experts including the top U.S. infectious disease expert Dr. Anthony Fauci have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the decades-old flu medication Tamiflu helps fight influenza. Such medications are seen as key to controlling future waves of infection and reducing the impact of the pandemic.

Merck’s pill works by interfering with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.

The U.S. government has committed to purchase 1.7 million doses of the drug if it is authorized by the FDA. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments worldwide. The company has not announced prices.

Several other companies, including Pfizer and Roche, are studying similar drugs that could report results in the coming weeks and months.

Merck had planned to enroll more than 1,500 patients in its late-stage trial before the independent board stopped it early. The results reported Friday included patients enrolled across Latin America, Europe and Africa. Executives estimated about 10% of patients studied were from the U.S.

[New Reporter]

Merck to seek emergency authorization for oral Covid treatment after ‘compelling results’ in trials

Oct 1 2021

• A phase 3 trial of Merck and Ridgeback Biotherapeutics’ oral antiviral treatment molnupiravir showed it reduced the risk of hospitalization or death by around 50% in Covid-19 patients.
• Merck plans to seek Emergency Use Authorization in the U.S. and submit marketing applications to other global drug regulators.
• If authorized by regulatory bodies, molnupiravir could be the first oral antiviral medicine for Covid-19.

Merck and Ridgeback Biotherapeutics plan to seek emergency authorization for their oral antiviral treatment for Covid-19, after the medicine showed “compelling results” in clinical trials.

The drug, molnupiravir, reduced the risk of hospitalization or death by around 50% for patients with mild or moderate cases of Covid-19, the companies announced on Friday. Molnupiravir is administered orally and works by inhibiting the replication of Covid-19 inside the body.

An interim analysis of a phase 3 study found that 7.3% of patients treated with molnupiravir were hospitalized within 29 days. Of the patients who received a placebo, 14.1% were hospitalized or died by day 29. No deaths were reported in patients who were given molnupiravir within the 29-day period, while 8 deaths were reported in placebo-treated patients

All 775 trial participants had laboratory-confirmed symptomatic Covid-19 and were randomly allocated either molnupiravir or a placebo within five days of the start of their symptoms.

Every participant was unvaccinated and had at least one underlying factor that put them at greater risk of developing a more severe case of the virus. The most common risk factors included obesity, being over the age of 60, diabetes and heart disease.

The phase 3 part of the trial was conducted at more than 170 sites, in countries including the U.S., Brazil, Italy, Japan, South Africa, Taiwan and Guatemala.

Molnupiravir’s efficacy was not affected by the timing of symptom onset or patients’ underlying risk factors, the study showed. It also proved to be consistently effective in treating all variants of Covid-19, including the widely dominant and highly transmissible Delta strain.

Adverse events were comparable in both the molnupiravir and placebo groups, with around 10% reporting adverse events. Just 1.3% of the molnupiravir group discontinued therapy due to an adverse event – less than the 3.4% of the placebo group who did so.

Recruitment into the study is being stopped early due to the positive results, at the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration.

Merck is currently also trialing molnupiravir in a separate global phase 3 study to evaluate its efficacy in preventing the spread of Covid-19 within households.

‘Profound impact’

Robert M. Davis, CEO and president of Merck, said in a press release on Friday that the company would do everything it can to bring molnupiravir to patients as quickly as possible.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global efforts to fight the pandemic,” he said.

Ridgeback Biotherapeutics CEO Wendy Holman added: “With the virus continuing to circulate widely, and because therapeutic options currently available are infused or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed.”

“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic,” she said.

Emergency Use Authorization

Merck said on Friday it plans to seek Emergency Use Authorization for the drug in the U.S. as soon as possible. The company also plans to submit marketing applications to other international drug regulators.

If authorized by regulatory bodies, molnupiravir could be the first oral antiviral medicine for Covid-19. Antiviral treatments currently in use, such as remdesivir, are administered intravenously.

Merck has already begun producing molnupiravir. The pharmaceutical giant expects to produce 10 million courses of treatment by the end of 2021, and more doses in 2022.

Earlier this year, Merck agreed to supply the U.S. with around 1.7 million courses of molnupiravir. This agreement is dependent on molnupiravir receiving Emergency Use Authorization or approval from the FDA.

Merck has also entered supply and purchase agreements for the drug with other governments – pending regulatory authorization – and is in discussions with other governments about the supply of molnupiravir.

The firm said on Friday that it plans to implement a tiered pricing approach based on World Bank country income criteria to ensure molnupiravir can be accessed globally. Merck has previously announced that it had entered into non-exclusive voluntary licensing agreements for molnupiravir with generic manufacturers, a move intended to assist low and middle-income countries in gaining access to the treatment. Those agreements are also pending approvals or emergency authorization by local regulators.

Profit share

Ridgeback received an upfront payment from Merck as part of the companies’ collaborative development of molnupiravir. The company is also eligible to receive contingent payments depending on developmental and regulatory approval milestones.

Profits arising from the collaboration will be split between Merck and Ridgeback equally.

[New Reporter]

Merck says experimental COVID-19 pill cut deaths, hospitalizations in half when given early

October 1, 2021

Washington — Merck & Co. said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.

If cleared, Merck's drug would be the first pill shown to treat COVID-19 — a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.

Merck and its partner, Ridgeback Biotherapeutics, said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and deaths as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered at higher risk for severe disease due to health problems such as obesity, diabetes or heart disease.

Among patients taking molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those getting the dummy pill. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck.

The results were released by the company and have not been peer reviewed. Merck said it plans to present them at a future medical meeting.

The Wall Street Journal says a government green light could mean people could take molnupiravir at home to try prevent hospitalization, adding that it's "on track to potentially be authorized by the end of the year."

The Journal says molnupiravir could become "a kind of Tamiflu" for COVID-19.

An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong. Company executives said they are in discussions with the Food and Drug Administration and plan submit the data for review in coming days.

"It exceeded what I thought the drug might be able to do in this clinical trial," said Dr. Dean Li, vice president of Merck research. "When you see a 50% reduction in hospitalization or death that's a substantial clinical impact."

Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.

Earlier study results showed the drug did not benefit patients who were already hospitalized with severe disease.

The U.S. has approved one antiviral drug, remdesivir, specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus. But all the drugs have to given by IV or injection at hospitals or medical clinics, and supplies have been stretched by the latest surge of the Delta variant.

Health experts including the top U.S. infectious disease expert Dr. Anthony Fauci have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the decades-old flu medication Tamiflu helps fight influenza. Such medications are seen as key to controlling future waves of infection and reducing the impact of the pandemic.

Merck's pill works by interfering with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.

The U.S. government has committed to purchase 1.7 million doses of the drug if it is authorized by the FDA. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments worldwide. The company has not announced prices.

Several other companies, including Pfizer and Roche, are studying similar drugs that could report results in the coming weeks and months.

Merck had planned to enroll more than 1,500 patients in its late-stage trial before the independent board stopped it early. The results reported Friday included patients enrolled across Latin America, Europe and Africa. Executives estimated about 10% of patients studied were from the U.S.