The world desperately needs coronavirus treatments, even if we get a vaccine
- Hundreds of potential Covid-19 treatments have entered clinical testing in the last several months.
- Some of those therapies are best suited to help during a certain stage of infection, while others target the body's inflammation response.
- We've rounded up the nine candidates that the scientific community finds most promising, including antibody therapeutics, plasma, and interferon drugs.
- Visit Business Insider's homepage for more stories.
The world has only eradicated one human infection in its history: smallpox.
Like most viruses, the novel coronavirus isn't likely to disappear from the population for good. Instead, the world's best hope is a combination of public-health measures, drug treatments, and a vaccine.
Under the most optimistic scenario, the US could be ready to manufacture a vaccine by the end of 2020. But by then, the virus is expected to kill an additional 23,000 people on top of the current death toll of 172,000, according to models from the University of Washington. And even if a vaccine becomes available, challenges in mass-producing and distributing it mean herd immunity is a long way off.
So one thing is certain: we need treatments and therapeutics no matter what else happens.
Hundreds of coronavirus treatments have entered clinical testing in the last several months. These include a range of candidates, from new medications that fight the virus directly to repurposed drugs that inhibit a runaway immune response.
"What we really need are drugs that, when given early, can prevent a symptomatic person from requiring hospitalisation or very dramatically diminish the time that they're symptomatic," Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told Facebook founder Mark Zuckerberg last month.
We've rounded up the nine treatments that the scientific community thinks are most promising right now. Most have entered human trials, and a few have already generated positive data.
The table below lists these drugs and treatments in alphabetical order.
Here's a rundown of the nine leading candidates.
Celltrion's antibody therapeutic uses the body's natural defences to fight infection
Many people who get the coronavirus develop neutralising antibodies — our body's natural response to a foreign pathogen. Fauci has called them "the gold standard of protection against a viral infection".
To make a therapeutic, scientists hunt for the most potent antibodies among a large pool collected from blood donations or animal testing. Then they clone and produce those antibodies at massive scale. There are now about 50 ongoing research programmes to develop antibody drugs against Covid-19.
Celltrion, a South Korean biotechnology company, launched a human trial for its antibody drug, CT-P59, in mid-July. The study is small — 32 healthy volunteers — and will focus on the drug's safety, but the company expects to know if its drug works as an effective treatment by the end of 2020.
The company also plans to launch studies in Europe by the end of the year to show whether the drug can treat mild and moderate cases. Another trial to test Celltrion's drug as a preventive tool should have results by the first quarter of 2021.
"Celltrion should never be underestimated," Ronny Gal, an industry analyst at AllianceBernstein, wrote to investors last month, adding the company has a "massive manufacturing footprint" and demonstrated ability to create antibody drugs.
Eli Lilly is testing its antibody drug in nursing homes
Eli Lilly is best-known for selling insulin, but the $143 billion pharma giant now has two antibody candidates for the coronavirus in human testing.
Its most advanced is LY-CoV555, an antibody drug developed with AbCellera, a small Canadian biotech company. Earlier this month, Lilly started a late-stage clinical trial that will test the drug in residents and staff members of nursing homes. The study will enroll up to 2,400 people to see if the medicine can prevent infections in places that have recently had confirmed cases.
Data showing whether the drug actually works should be available in the fourth quarter of 2020. Lilly hopes to have several hundred thousand doses of a treatment available by the end of this year.
In a recent interview with Insider, Bill Gates said antibody drugs could "cut the death rate quite dramatically" among coronavirus patients.
Regeneron wants to see if its antibody drug can prevent infections
Biotech company Regeneron is a leader in crafting antibody therapeutics. The company has engineered mice to produce antibodies that mimic the human immune system through a technology platform called VelocImmune. That technology has produced several approved drugs, including an antibody drug against the Ebola virus, which helps lower patients' risk of death.
In June, Regeneron started clinical trials for REGN-COV2, its two-antibody cocktail. These initial trials focus on patients already infected with the coronavirus — one for hospitalised patients and one for less severe, non-hospitalised cases. Data from the first 30 patients already suggests the drug could be safe for humans, the company said in early July.
REGN-COV2 is also being studied as a preventive treatment — Regeneron launched a trial for that purpose last month. The study is designed to test people who have close exposure to the virus, such as someone living with an infected person. Researchers expect to enroll about 2,000 participants across 100 sites.
The company expects initial data by the end of September, by which point Regeneron expects to be manufacturing hundreds of thousands of prophylactic doses per month or tens of thousands of treatment doses, according to a recent investor call.
Convalescent plasma could keep mild cases from getting severe
Convalescent plasma therapy dates back to the 1918 Spanish flu pandemic, when it helped reduce mortality among people with acute infections. Since antibodies develop in plasma, the liquid portion of blood, doctors can transfer this plasma intravenously to a coronavirus patient. If the treatment works, the new patient would also mount an antibody response to the virus. In theory, it could prevent a mild case from becoming more severe.
So far, a Mayo Clinic study that's still awaiting peer review found that plasma therapy can reduce mortality among hospitalised patients by 57%. Mayo Clinic researchers also determined that the treatment was relatively safe among 5,000 adults with severe or life-threatening cases.
Already, the US Food and Drug Administration is allowing more than 2,700 hospitals to administer plasma therapy through an expanded access trial led by the Mayo Clinic. The trial had delivered plasma to more than 97,000 patients as of Tuesday, according to the program website.
The FDA was prepared to authorize convalescent plasma for emergency use as of last week, according to the New York Times, but federal health officials, including Fauci, decided to put the plan on ice until more data from randomized control trials becomes available. The authorisation would allow doctors to administer the treatment earlier in the course of an infection, when it's believed to be most effective.
Dexamethasone is a cheap option for patients with acute cases
One of the biggest surprises in Covid-19 research so far has been dexamethasone. The cheap, generic steroid significantly reduced the chances that critically ill patients would die in a major UK clinical trial.
Dexamethasone reduced the number of deaths by one-third for people on ventilators and cut deaths by 20% among patients with Covid-19 who were getting extra oxygen.
"When you have late disease, it's less the virus doing damage than the aberrant inflammatory response, which is the reason why dexamethasone works," Fauci said in July.
The UK government has given immediate authorisation for dexamethasone to be used as a standard treatment for seriously ill Covid-19 patients. US treatment guidelines also recommend using the steroid in patients on ventilators or needing oxygen support, although the FDA has not issued an emergency use authorisation.
Hyperimmune globulin could buy time until a vaccine hits the market
In May, a coalition of medical institutions, drug companies, nonprofits, and Covid-19 survivors launched "The Fight Is In Us": a campaign to get more recovered coronavirus patients to donate blood. Some of that blood will be used for direct transfusions, and the rest will go toward manufacturing hyperimmune globulin, a drug made from convalescent plasma.
The process of creating hyperimmune globulin involves pooling plasma from recovered patients and heat-treating it so that any remaining pathogens get destroyed. The result is a vial of medicine with consistent antibody levels that can easily be administered to patients. The drug focuses on the most common antibody found in blood — immunoglobulin G (IgG) — which usually confers long-term immunity.
Japan's largest pharmaceutical company, Takeda, and Pennsylvania-based biotech CSL Behring are now leading a coalition of 10 drug companies involved in the "The Fight Is In Us" campaign. They're hoping to determine whether hyperimmune globulin improves outcomes for coronavirus patients with severe cases.
"Our goal here isn't to continue to produce hyperimmune globulin ad infinitum," Christopher Morabito, head of research and development for plasma-based therapies at Takeda, previously told Business Insider. "Our goal here is to have an effective therapy to bridge us to a point where either the pandemic is over because it dies out, or because there's a vaccine available, or until there are many more effective treatments for patients with this disease."
The coalition hopes to secure FDA approval by the end of 2020.
Merck KGaA's interferon drug is being paired with other promising therapies
Interferons are our bodies' first line of defence against the coronavirus. But early research suggests that the virus may disable these proteins, which then leads to an even more aggressive immune response.
Drugmakers are now testing whether a boost of interferons could help ward off severe infection.
Doctors already use Rebif, an interferon injection from German biopharmaceutical company Merck KGaA, to treat patients who relapse from multiple sclerosis. The company hopes that same drug might prevent the coronavirus from replicating in humans, while also reducing inflammation.
The drug is being tested in conjunction with other therapies like lopinavir (an HIV antiviral) and remdesivir, which was developed as a treatment for Ebola. The National Institute of Allergy and Infectious Diseases launched a phase-three clinical trial in early August to see whether Rebif and remdesivir could shorten recovery times in coronavirus patients. The study, which hopes to enroll 1,000 patients, could yield preliminary results this fall.
Merck & Co.'s antiviral pill could be administered right after someone tests positive
Antivirals work by targeting a virus to keep it from replicating inside the body. Since they're already used to treat the flu and HIV, some researchers think they could represent the future of coronavirus therapy.
"As soon as somebody comes in with a positive test, bingo, you hit 'em with an antiviral and you're done. That's what I see for the future," Fauci said earlier this month. "Quite frankly, there really is no reason why we couldn't do that. There's no reason why that's not possible. Heck, if we did it for HIV, we can do it for coronavirus."
US pharmaceutical company Merck & Co. is working with biotech company Ridgeback Biotherapeutics to develop MK-4482, an antiviral administered in pill form. The drug, originally designed as a flu treatment, has been shown to prevent multiple coronaviruses from replicating in mice. Research has also shown it can prevent the new coronavirus (SARS-CoV-2) from replicating in human cells inside a laboratory — but that doesn't necessarily mean it will work on patients.
The drug's phase-two trial is set to end in September. Merck plans to launch two phase-three trials that same month to study the effects of the drug in both hospitalised coronavirus patients and coronavirus outpatients. The goal is to see whether the treatment shortens symptoms or prevents cases from getting worse.
In a July call with investors, Merck's research chief, Roger Perlmutter, said the company could be ready to deliver "millions of doses" before next year.
Remdesivir is the only treatment approved for emergency use by the FDA
Only one antiviral has been given emergency authorisation to treat Covid-19: Gilead Sciences' remdesivir. The company has been working on the drug since 2009. Study results have shown that it helps hospitalised patients with Covid-19 recover faster.
Because it had already been tested in Ebola patients, remdesivir was shown to be safe for humans to take for Covid-19. The FDA issued an emergency authorisation for the drug's use on May 1. After donating its drug supply for two months, Gilead announced in June that it will charge governments of developed countries $2,340 for a five-day treatment course of remdesivir.
Gilead submitted remdesivir for official approval with the FDA this month. The company is also testing an inhaled version of the drug, with the hopes of making it available to non-hospitalized patients.
Though remdesivir and dexamethasone are considered the two biggest advances in coronavirus treatments so far, the drug landscape is constantly changing. The industry publication Biocentury offers a full list of therapies under development for Covid-19. It's possible that other medications on that list could edge ahead in the coming months.
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