Results are coming that affect the pandemic

  • Companies are struggling to develop a pill that can treat COVID-19.
  • Drug manufacturers like Pfizer and Merck expect results on their oral antiviral programs by the end of the year.
  • An effective, easy to take treatment can play a big role along with vaccines.

Another COVID-19 breakthrough may be just weeks away, but this time with pills instead of shots.

Three of the largest drug manufacturers — Merck, Pfizer, and Roche — expect late trial results by the end of the year for experimental antiviral drugs. If successful, these treatments can fill a gap not covered by vaccines: help already infected people recover faster. They may even prevent people from getting sick in the first place.

These oral drugs can change the way doctors treat mild and moderate COVID-19 cases and “lower people’s risk perception of the pandemic,” Matthew Harrison, a biotechnological analyst at Morgan Stanley, wrote in a September 27 research note.

As the tension builds as pharmaceutical giants launch more studies, don’t expect a miracle cure. If these antivirals work and are safe – which is still to be seen – they are likely to help only in certain circumstances. Researchers working on these drugs say they are likely to work best as an early treatment, meaning they will not be of much use to people who are seriously ill.

A simpler and cheaper treatment

COVID-19 pills are an enticing perspective. They are easier to mass produce and administer compared to antibody drugs suitable for the treatment of COVID-19. The antibody therapies are typically given as an infusion of hour-long IV, followed by another hour of monitoring of side effects. The three leading antiviral programs are tested as 10 pills: two capsules every 12 hours over five days.

The pills are probably also cheaper than the antibody infusions, which are free for patients but cost the US government more than $ 1,000 per day. Dosage.

These new drugs may supplement vaccines. While the vaccines are extremely protective, they also have their limitations. A fraction of people simply refuse to be vaccinated. Some who get the shot, like those with severe immune system weaknesses, fail to mount an immune response from the vaccine. And uncertainty lingers for everyone about how well the vaccines stop transmission, as well as how long the protection lasts, especially as the virus continues to mutate.

“We still do not understand how the continued viral development will broadly affect the effectiveness of the vaccine,” said Daria Hazuda, vice president of infectious disease detection at Merck, which is leading research into a COVID-19 pill. “There is still an important role for antiviral drugs.”

Antiviral drugs would be “another piece of the bigger puzzle of solving the COVID problem,” said Bernadette Boden-Albala, director of the University of California Public Health Program, Irvine, who is not involved in the research.

But Boden-Albala said she was concerned that the public health system would not be equipped with quick-access tests and an easy way to quickly write and dispense prescriptions to millions of patients in the United States with the virus. The Biden administration is not working fast enough to build that system now to take full advantage of these drugs if they work, she said.

“We just have to get the process right — that’s been our problem,” Boden-Albala said. “We have significant process problems and the public health infrastructure is so fragile and needs to be rebuilt.”

Merck, Pfizer and Roche are leading the race for a COVID-19 pill

Molnupiravir capsules, an antiviral drug developed by Merck and Ridgeback Biotherapeutics that could treat COVID-19

Molnupiravir is an experimental oral antiviral developed by Merck and Ridgeback Biotherapeutics that could treat COVID-19.

Merck


In the sprint for results, industry analysts expect Merck to be first. Company executives said in July that they could get results at a later date in October. Recently, a company spokesman told Insider that the official timeline for results was before the end of 2021.

New Jersey pharma is developing an antiviral drug called molnupiravir, which was originally developed as a treatment for the flu. The company licensed the drug in July 2020 from Ridgeback Biotherapeutics, a small biotechnology company in Miami. The federal government is investing heavily in molnupiravir and in June agreed to buy enough pills to treat 1.7 million people. This $ 1.2 billion deal is conditional on the Food and Drug Administration approving the treatment.

Merck completes a study of 1,850 volunteers with mild to moderate COVID-19 receiving randomized molnupiravir or placebo pills. The main goal is to see if fewer patients on molnupiravir are hospitalized or die after 29 days compared to those receiving placebo.

In general, antiviral drugs start a war against the virus inside our cells. Viruses hijack our cells and convert them into copiers. Antivirals try to block that replication process. Drugs such as molnupiravir, called nucleosides, intentionally insert errors in the copying process and prevent the virus from seeking to replicate.

This process also means that antiviral agents are typically most potent when given earlier, when replication is limited. In April, Merck stopped testing his drug in hospitalized COVID-19 patients, saying preliminary data suggested it did not help those patients.

The Swiss pharmaceutical giant Roche is also developing a nucleoside called AT-527 with a small Boston biotech called Atea Pharmaceuticals. This drug was tested as a hepatitis C antiviral before the pandemic broke out. Preliminary results announced in June from a small clinical study showed potential for the drug, but upcoming data will be more definitive. Roche expects results before the end of the year from a study that tested AT-527 against placebo in 1,386 people with mild or moderate COVID-19.

Roche Pharmaceuticals CEO Bill Anderson believes that oral antiviral drugs are the most promising treatments in the industry’s pipeline, he said at a news conference on September 7. Roche’s anti-inflammatory drug Actemra, which is authorized in the United States to treat inpatients COVID-19 patients, only helps when patients are facing serious illness and struggling to breathe, Anderson said.

“You really want to be able to treat people before they get so sick,” he said.

Finally, there is Pfizer’s antiviral program that works a little differently by blocking a protease enzyme that plays a key role in the virus’ copying process. Pfizer is testing this antiviral agent in combination with a low dose of ritonavir, another antiviral agent that slows the breakdown of Pfizer’s medication so that it lasts longer in the body.

In July, Pfizer launched a 3,000 voluntary study of non-hospitalized COVID-19 patients in hopes of reducing hospitalization and mortality compared to a placebo group. Pfizer wants results before the end of the year for the survey, which could support an emergency aid application if successful, a company spokesman told Insider.

Disease prevention pills

A head shot by Enanta Pharmaceuticals CEO Jay Luly

Jay Luly, CEO of Enanta Pharmaceuticals.

Dina Rudick / Boston Globe via Getty Images


Other drug developers are betting that there will be room for improvement beyond this first wave of oral antiviral drugs. These companies include Enanta Pharmaceuticals, a small biotechnology company in Massachusetts that wants to launch the first human test early next year for its own coronavirus pill.

“Just because you have something going forward that you want data by the end of the year, does not mean it will be good data,” Enanta CEO Jay Luly told Insider.

There are also clinical trials of giving antiviral drugs even earlier – before people get sick.

Merck and Pfizer are already recruiting volunteers for prophylaxis trials, which are designed to see if their pills will initially prevent infection and symptomatic disease. Both studies recruit people who live with someone who has symptomatic COVID-19. Roche also plans to start a similar prevention study before the end of the year.

“We know that antivirals, even in these acute respiratory infections, work really well as prophylaxis,” Mercks Hazuda said.

HIV treatment research is the most compelling example of this, Hazuda said; Pre-exposure prophylaxis treatment of HIV is up to 99% effective in preventing infection after exposure to the virus. The same concept has been the case for treatments with influenza and respiratory syncytial virus, she added.

Hazuda also said she saw a role for Merck’s antivirals in addition to COVID-19 in dealing with future pandemic threats. Molnupiravir, Hazuda said, has shown activity against a variety of viruses in laboratory studies, including Ebola. Although it has a long way to go from being an effective treatment, it can help prepare for future pathogens, she said.

“We are very excited that it could easily be something we have available and that could play an important role in future zoonotic transmissions of other coronaviruses, as well as future outbreaks of new strains of influenza viruses,” she said.

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