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- Companies are rushing to develop a pill that can treat COVID-19.
- Drugmakers like Pfizer and Merck expect results on their oral antiviral programs before the end of the year.
- An effective and easy-to-take treatment could play a big role alongside vaccines.
Another COVID-19 breakthrough could be in a few weeks, but this time with pills instead of bites.
Three of the biggest drugmakers – Merck, Pfizer and Roche – expect advanced test results before the end of the year for investigational antiviral drugs. If successful, these treatments could fill a gap not covered by vaccines: helping those already infected to recover faster. They might even be able to prevent people from getting sick in the first place.
These oral drugs could change the way doctors treat mild and moderate COVID-19 cases and “reduce people’s perceptions of pandemic risk,” Morgan Stanley biotechnology analyst Matthew Harrison wrote in a note from September 27 research.
As the excitement builds as the pharmaceutical giants launch more studies, don’t expect a quick fix. Whether these antivirals work and are safe – which remains to be seen – they will likely only be useful under certain circumstances. Scientists working on these drugs say they are likely to work best as an early treatment, which means they won’t be of much use to seriously ill people.
Simpler and cheaper treatment
COVID-19 pills are a tantalizing prospect. They are simpler to produce and administer in bulk, compared to antibody-based drugs that are suitable for treating COVID-19. Antibody therapies are usually given as an hour-long IV infusion, followed by another hour of monitoring for side effects. The three main antiviral programs are tested in the form of treatment regimens of 10 tablets: two capsules every 12 hours for five days.
The pills are also likely to be cheaper than antibody infusions, which are free to patients but cost the US government over $ 1,000 per dose.
These new drugs could complement vaccines. Although vaccines are highly protective, they also have their limitations. A fraction of people simply refuse to be vaccinated. Some of those who do get the vaccine, such as those with severe weaknesses in the immune system, fail to develop an immune response from the vaccine. And uncertainty persists for everyone about how vaccines stop transmission, as well as how long they will be protected, especially as the virus continues to mutate.
“We still don’t understand how the continued viral evolution is going to have a general impact on the effectiveness of the vaccine,” said Daria Hazuda, vice president of infectious disease discovery at Merck, who leads research on a COVID pill. -19. “There is still an important role for antivirals.”
Antivirals would be “one more piece of the larger puzzle of solving the COVID problem,” said Bernadette Boden-Albala, director of the public health program at the University of California, Irvine, who is not involved in the research.
But Boden-Albala said she was concerned the public health system might not be equipped with widely available rapid tests and an easy way to quickly write and dispense prescriptions for the millions of patients in the United States with the. virus. The Biden administration is not working fast enough to build this system now to take full advantage of these drugs if they work, she said.
“We just have to get the process right – that’s our problem,” Boden-Albala said. “We have major process issues and the public health infrastructure is so fragile and needs to be rebuilt.”
Merck, Pfizer and Roche lead race for COVID-19 pill
Molnupiravir is an experimental oral antiviral developed by Merck and Ridgeback Biotherapeutics that could treat COVID-19.
Merck
In the sprint to results, industry analysts expect Merck to be first. Company executives said in July they could have late results in October. More recently, a company spokesperson told Insider that the official results schedule is before the end of 2021.
The New Jersey pharmaceutical company is developing an antiviral called molnupiravir, which was originally developed as a treatment for the flu. The company licensed the drug in July 2020 to Ridgeback Biotherapeutics, a small biotechnology company in Miami. The federal government is betting big on molnupiravir, agreeing in June to buy enough pills to treat 1.7 million people. This $ 1.2 billion deal is subject to approval of the treatment by the Food and Drug Administration.
Merck is completing a study with 1,850 volunteers with mild to moderate COVID-19 who are randomly given either molnupiravir or placebo pills. The main objective is to see if fewer patients on molnupiravir are hospitalized or die after 29 days compared to those on placebo.
Usually, antivirals start a war against the virus inside our cells. Viruses hijack our cells and turn them into copying machines. Antivirals try to block this process of replication. Drugs like molnupiravir, called nucleosides, intentionally insert errors into the copying process, obstructing the virus’s quest to replicate.
This process also means that antivirals are generally more potent when given earlier, when replication is limited. In April, Merck stopped researching its drug in hospitalized COVID-19 patients, saying interim data suggested it had not helped those patients.
Swiss drug giant Roche is also developing a nucleoside called AT-527 with a small biotech from Boston called Atea Pharmaceuticals. This drug was being researched as an antiviral against hepatitis C before the pandemic broke out. Preliminary results announced in June from a smaller clinical study showed potential for the drug, but future data will be more definitive. Roche is awaiting results before the end of the year from a study testing AT-527 against a placebo in 1,386 people with mild or moderate COVID-19.
Roche Pharmaceuticals CEO Bill Anderson believes oral antivirals are the most promising treatments in the industry pipeline, he said at a press briefing on Sept. 7. Roche’s anti-inflammatory drug Actemra, which is licensed in the United States to treat COVID-19 hospital patients, only helps when patients are facing serious illness and have trouble breathing, Anderson said.
“You really want to be able to cure people before they get so sick,” he said.
Finally, there’s Pfizer’s antiviral program, which works slightly differently by blocking a protease enzyme that plays a key role in the virus’s copying process. Pfizer is testing this antiviral in combination with a low dose of ritonavir, another antiviral which slows down the breakdown of Pfizer’s medicine so that it lasts longer in the body.
In July, Pfizer launched a 3,000-volunteer study of out-of-hospital COVID-19 patients, hoping to reduce hospitalization and death rates compared to a placebo group. Pfizer wants to have results before the end of the year for this study, which could support a successful emergency clearance case, a company spokesperson told Insider.
Pills to prevent disease
Jay Luly, CEO of Enanta Pharmaceuticals.
Dina Rudick / The Boston Globe via Getty Images
Other drug developers are betting there will be room for improvement beyond this first wave of oral antivirals. Those companies include Enanta Pharmaceuticals, a small biotechnology company in Massachusetts looking to begin the first human testing early next year for its own coronavirus pill.
“Just because you have something in the future that you have data by the end of the year doesn’t mean that it will be good data,” Jay Luly, CEO of Enanta, told Insider.
There are also clinical trials to give antivirals 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 prevent infections and symptomatic illnesses in the first place. Both studies are recruiting people who live with someone with symptomatic COVID-19. Roche also plans to launch a similar prevention study before the end of the year.
“We know that antivirals, even in these acute respiratory infections, work very well as a prophylaxis,” said Hazuda of Merck.
The most compelling example is HIV treatment research, Hazuda said; HIV pre-exposure prophylaxis is up to 99% effective in preventing infection after exposure to the virus. The same concept has been found to be true for treatments for influenza and respiratory syncytial virus, she added.
Hazuda also said she sees a role for Merck’s antiviral beyond COVID-19 in tackling future pandemic threats. Molnupiravir, Hazuda said, has shown activity against a variety of viruses in laboratory studies, including Ebola. While there is a long way to go before it is an effective treatment, it could help prepare against future pathogens, she said.
“We are very excited that this could be something that we have easily on hand that could play an important role in future zoonotic transmissions of other coronaviruses, as well as in future outbreaks of new strains of the virus. the flu, ”she said.
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