New coronavirus treatments expected by late fall
WASHINGTON - The Trump administration is hoping that a sophisticated new drug treatment to prevent people from getting severely ill from COVID-19 will be available to the public by this fall.
But experts in the field say that treatments most likely to reach the market in September or October are more modest, repurposed therapeutic drugs meant to treat late-stage symptoms of the illness.
Hundreds of treatments and antivirals are currently undergoing U.S. clinical trials. But the potential drugs that are furthest along in the process are medications already on the market to treat other illnesses or have been under review for many years.
Many of those are anti-inflammatory and blood clot treatments that could mitigate the severity of the disease, decrease hospital stays and reduce fatalities.
The success of these more modest drugs would be less dramatic than a tailor-made treatment that could prevent the disease from progressing to a life-threatening state. But they could still alter the dynamics of an expected autumn wave of the coronavirus pandemic in the United States, which already has taken over 138,000 lives and continues to ripple across the country.
"If you look at the pipeline, there are more shots on goal on the treatment side - the late-stage inflammatory issues," said David Thomas, vice president of industry research at BIO, a major trade association representing biotechnology companies and institutions. "The goal would be to have more therapeutics that would decrease the severity of the late-stage disease."
The hope is that these drugs might help lower the death toll and the burden on intensive care units in hospitals.
Experts compare the impact of these drugs to that of remdesivir, the most prominent repurposed, antiviral treatment currently available to coronavirus patients. The drug is produced by Gilead Sciences and was originally tested for its effectiveness against other infectious diseases, including the SARS and MERS coronaviruses.
Preliminary clinical trials on the effects of remdesivir in coronavirus patients found that the drug has reduced hospitalization times. More robust clinical trials will be necessary to determine the extent to which the drug helps patients recover.
"You have this emergent need for therapeutics, and people are taking everything they have off the shelf," said Dr. Lawrence Blatt, chief executive officer of Aligos Therapeutics, a California-based biotechnology company currently working on a therapeutic candidate for COVID-19. "The net result is that most of the therapeutics that are in clinical trials right now are either not going to be effective or will have marginal benefit."
"Let's think of it like a lock and key. Each virus has its own lock," Blatt continued. "If you took your key from one door and tried to unlock another door, it wouldn't work very well. You have to make a key for that door specifically."
A specific "key" is the gold standard for a coronavirus treatment, and is the current goal of the federal government, which this month placed a $450 million bet on an experimental drug cocktail that could help infected individuals beat back the coronavirus at earlier stages of infection - or even prevent infection in the first place.
"We are investing in the candidates that are furthest along so that we could have products by early fall of 2020," a senior administration official working on Operation Warp Speed, the government program to expedite the discovery and production of a coronavirus vaccine, said referring to therapeutics.
"While we think it is fair to say that vaccine progress is occurring at 'warp speed' pace, faster than any vaccine has been developed in history, therapeutics are even faster, and we believe we'll have new options for saving American lives as soon as the early fall," the official told reporters last week.
The drug cocktail, produced by Regeneron, is being made from scratch to address the coronavirus using what is known as "monoclonal antibodies" - protective proteins that have been identified by lab scientists and produced on a large scale to fight off the virus.
It is unclear whether the project will succeed - Regeneron has pulled another monoclonal antibody treatment designed to treat rheumatoid arthritis from consideration as a COVID-19 treatment. If the new drug cocktail works, only 300,000 doses will be available by the end of autumn, far short of expected demand.
That would leave doctors and nurses still largely relying on the other repurposed, late-stage treatments, even if Regeneron's product ultimately proves successful.
"We know that vaccines will take a while, so there's been a lot of discussion about using different kinds of drugs - some old drugs," said David Eller, the chairman, co-founder and chief executive officer of Celltex Therapeutics, a Texas-based biotech company conducting Phase II clinical trials for a stem cell treatment of COVID-19. "The real issue is, we need something today."
Still, the less ambitious, late-stage treatments that have shown promise could blunt two of the main phenomena identified, up to this point, as fatal to severely ill COVID-19 patients: hyperinflammation and blood clotting.
"The lung only fails in so many different ways, and it doesn't matter if it's SARS CoV-2, or influenza, or metapneumovirus," said Richard Boucher, director of the Marsico Lung Institute at the University of North Carolina School of Medicine, explaining why he believes some repurposed drugs currently under consideration to treat COVID-19 patients could work. "It's going to be therapies that are going to be useful, but are going to be incremental."
Last month, Boucher released a major study on how the coronavirus primarily infects the respiratory tract through the nose - a critical finding in the search for therapeutics.
Treatments that attempt to mobilize the power of the immune system are proving far more complicated to achieve, Boucher said.
"There's no question that antivirals would be better if you can get them in early," he said. "But the second half of the disease, which is immune mediated, is going to be complex. It's a delicate balance. I mean, we're on a knife's edge all the time immunologically."
Some scientists are hopeful that the chances of achieving a simpler, early-stage treatment will increase the more they learn about the nature of the coronavirus.
In Miami-Dade County in Florida, Dr. Gustavo Ferrer, president of the Aventura Pulmonary Institute, is working on a therapeutic method recently submitted to the Food and Drug Administration for review that might diminish the viral load of a new infection using a simple nasal spray.
Addressing the potency of the virus early on in the infection would prevent the disease from progressing to a serious stage, and could help mitigate its contagiousness, Ferrer said.
Pharmaceutical companies, he said, "are focusing on treating people who have moderate to severe disease."
"The great majority of people have mild to moderate symptoms and never get to respiratory failure," Ferrer added. "But those people are the ones passing the virus, and we're not using anything to control the viral load in that group other than using masks and social distancing."
Five months since the coronavirus outbreak became apparent nationwide, only a handful of treatments have been authorized by the FDA for emergency use on severely ill patients.
The Trump administration's focus remains on monoclonal antibody drugs as well as treatment methods that harness antibodies from the blood donations of recently recovered coronavirus patients - convalescent plasma and hyperimmune globulin treatments.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, is leading the agency's effort to identify therapeutic drugs for the coronavirus. She told reporters last week that the government has been unable to stockpile convalescent plasma because donations are being used up in the current wave of cases across the southern states.
"We are in the midst of an outbreak at the moment," said Woodcock. "We're doing everything we can to make it available."
Without a strategic supply of convalescent plasma and a massive stockpile of FDA-approved monoclonal antibody drugs to meet demand, the best hope for the fall might well be more modest drugs that can slow down the death rate, experts say.
Over 286 treatments, 192 antiviral drugs and 169 vaccines are currently undergoing clinical trials in the United States, according to a BIO database of coronavirus therapeutic development.
White House press secretary Kayleigh McEnany said last week that therapeutics already in use - like remdesivir and convalescent plasma - are examples of successes in the U.S. response to the pandemic.
President Donald Trump, at a press conference on Tuesday, said that more therapeutics would "hopefully" be distributed in the near future.
"People are feeling good about our country," Trump said. "People are feeling good about therapeutics and possible vaccines."