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Merck Says COVID-19 Pill Cuts Risk of Death, Hospitalization

Matthew Perrone wrote . . . . . . . . .

In a potential leap forward in the global fight against the pandemic, drugmaker Merck said Friday that its experimental pill for people sick with COVID-19 reduced hospitalizations and deaths by half.

If cleared by regulators, it would be the first pill shown to treat COVID-19, adding a whole new, easy-to-use weapon to an arsenal that already includes the vaccine.

The company said it will soon ask health officials in the U.S. and around the world to authorize the pill’s use. A decision from the U.S. Food and Drug Administration could come within weeks after that, and the drug, if it gets the OK, could be distributed quickly soon afterward.

All other COVID-19 treatments now authorized in the U.S. require an IV or injection. A pill taken at home, by contrast, would ease pressure on hospitals and could also help curb outbreaks in poorer and more remote corners of the world that don’t have access to the more expensive infusion therapies.

“This would allow us to treat many more people much more quickly and, we trust, much less expensively,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University who was not involved in the research.

Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as those who received a dummy pill.

The study tracked 775 adults with mild-to-moderate COVID-19 who were considered high risk for severe disease because of health problems such as obesity, diabetes or heart disease. The results have not been reviewed by outside experts, the usual procedure for vetting new medical research.

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. After that time period, there were no deaths among those who received the drug, compared with eight in the placebo group, according to Merck.

The results were so strong that an independent group of medical experts monitoring the trial recommended stopping it early.

Company executives said they plan to submit the data to the FDA in the coming days.

Even with the news of a potentially effective new treatment, experts stressed the importance of vaccines for controlling the pandemic, given that they help prevent transmission and also reduce the severity of illness in those who do get infected.

White House coronavirus coordinator Jeff Zients said that vaccination will remain the government’s main strategy for controlling the pandemic. “We want to prevent infections, not just wait to treat them when they happen,” he said.

Dr. Anthony Fauci, the government’s foremost authority on infectious diseases, called the results from Merck “very good news.”

Merck only studied its drug in people who were not vaccinated. But FDA regulators may consider authorizing it for broader use in vaccinated patients who get breakthrough COVID-19 symptoms.

Andrew Pekosz of Johns Hopkins University predicted vaccines and antiviral drugs would ultimately be used together to protect against the worst effects of COVID-19.

“These shouldn’t be seen as replacements for vaccination — the two should be seen as two strategies that can be used together to significantly reduce severe disease,” said Pekosz, a virology specialist.

Patients take four pills of molnupiravir twice a day for five days. Side effects were reported by both groups in the Merck trial, but they were slightly more common among those who 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. That’s not surprising, given that antiviral drugs are most effective when used before the virus ramps up in the body.

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

The antibody drugs have been shown to reduce hospitalization and death by roughly 70% when given to high-risk patients, roughly 20 percentage points more than Merck’s pill. But experts cautioned against comparing results from the two, given the preliminary nature of Merck’s data.

Health experts, including Fauci, have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way Tamiflu is given to help speed recovery from the flu.

Like other antivirals, Merck’s pill works by interfering with the virus’s ability to copy its genetic code and reproduce itself.

The U.S. government has committed to purchasing enough pills to treat 1.7 million people, assuming the FDA authorizes the drug. Merck said it can produce pills for 10 million patients 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 and 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 across Latin America, Europe and Africa. Executives estimated 10% of patients studied were from the U.S.


Source : AP


Read more at Merck

Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study . . . . .

90% of COVID-19 Patients Treated with New Israeli Drug Discharged in 5 days

Some 93% of 90 coronavirus serious patients treated in several Greek hospitals with a new drug developed by a team at Tel Aviv’s Sourasky Medical Center as part of the Phase II trial of the treatment were discharged in five days or fewer.

The Phase II trial confirmed the results of Phase I, which was conducted in Israel last winter and saw 29 out of 30 patients in moderate to serious condition recover within days.

“The main goal of this study was to verify that the drug is safe,” Prof. Nadir Arber said. “To this day we have not registered any significant side effect in any patient from both groups.”

The trial was conducted in Athens because Israel did not have enough relevant patients. The principal investigator was Greece’s coronavirus commissioner, Prof. Sotiris Tsiodras.

Arber and his team, including Dr. Shiran Shapira, developed the drug based on a molecule that the professor has been studying for 25 years called CD24, which is naturally present in the body.

“It is important to remember that 19 out of 20 COVID-19 patients do not need any therapy,” Arber said. “After a window of five to 12 days, some 5% of the patients start to deteriorate.”

The main cause of the clinical deterioration is an over activation of the immune system, also known as a cytokine storm. In case of COVID-19 patients, the system starts attacking healthy cells in the lungs.

“This is exactly the problem that our drug targets,” he said.

CD24 is a small protein that is anchored to the membrane of the cells and it serves many functions including regulating the mechanism responsible for the cytokine storm.

Arber stressed that their treatment, EXO-CD24, does not affect the immune system as a whole, but only targets this specific mechanism, helping find again its correct balance.

“This is precision medicine,” he said. “We are very happy that we have found a tool to tackle the physiology of the disease.”

“Steroids for example shut down the entire immune system,” he further explained. “We are balancing the part responsible for the cytokine storms using the endogenous mechanism of the body, meaning tools offered by the body itself.”
Arber noted that another breakthrough element of this treatment is its delivery.

“We are employing exosomes, very small vesicles derived from the membrane of the cells which are responsible for the exchange of information between them,” he said.

“By managing to deliver them exactly where they are needed, we avoid many side effects,” he added.

The team is now ready to launch the last phase of the study.

“As promising as the findings of the first phases of a treatment can be, no one can be sure of anything until results are compared to the ones of patients who receive a placebo,” he said.

Some 155 coronavirus patients will take part in the study. Two-thirds of them will be administered the drug, and one-third a placebo.

The study will be conducted in Israel and it might be also carried out in other places if the number of patients in the country will not suffice.

“We hope to complete it by the end of the year,” Arber said.

If the results are confirmed, he vowed that the treatment can be made available relatively quickly and at a low cost.
“In addition, a success could pave the wave to treat many other diseases,” he concluded.


Source : The Jerusalem Post


Read also at The Times of Israel

New Israeli drug cured 29 of 30 moderate/serious COVID cases in days — hospital . . . . .