- A coronavirus drug breakthrough has been able to both treat and prevent COVID-19 infections in early tests, and it could be a huge development before vaccines are ready.
- Monoclonal antibody therapies target the virus’s ability to replicate inside the body, and several companies have started clinical trials.
- Regeneron will conduct four distinct random trials for a drug called REGN-COV2, which contains two potent antibodies that should also block the virus if it mutates.
A report in early May said that revolutionary new coronavirus drugs might be ready this summer, referring to monoclonal antibody therapies that were in development at several pharmaceutical companies. These are medications that incorporate the chemical substances capable of blocking the virus from replicating once a person is infected. That’s actually what the immune system does when a new pathogen is discovered. It creates special antibodies that can counteract that particular infection and provide immunity against future infections. That’s actually what vaccines do, too. They train the body to produce the right antibodies early, which then can prevent infection. That’s why monoclonal antibodies are so desirable — they can provide short-term immunity to patients and treat people who can’t fight the virus on their own.
Since May, we saw a few of the companies involved in monoclonal antibody drug development announce clinical trials, and Regeneron Pharmaceuticals is the latest one to go forward with testing on humans. The company will conduct four separate trials that are meant to study the efficacy and safety of monoclonal therapies for both treating COVID-19 cases and preventing the infection.
The REGN-COV2 is a cocktail of two antibodies that are supposed to block the virus’s spike protein in two separate locations. The key to the treatment isn’t just to improve the condition of patients and provide temporary immunity, but also to prevent the virus from mutating and “escaping” the treatment while fighting the antibodies.
“We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral ‘escape,’ a critical precaution in the midst of an ongoing global pandemic,” President and Chief Scientific Officer of Regeneron George D. Yancopoulos said in a statement.
“REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick – and could be available much sooner than a vaccine. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines. Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches.”
Regeneron also announced two studies that show REGN-COV2’s ability to block mutated coronavirus versions, but they will be published to next week based on lab work that preceded the studies. The company says that monoclonal antibody drugs that contain more than one effective antibody are more likely to prevent the virus from escaping neutralization by mutation:
Viral escape is when, under pressure from an anti-viral therapeutic, spontaneously arising mutant forms of the virus are able to ‘escape’ or evade the therapeutic’s blocking action. These mutants are then ‘selected’ (i.e., are able to survive and proliferate despite the single therapeutic treatment) and may ultimately become the dominant strain of the virus.
The company says it studied thousands of fully-human antibodies that were produced using its own Velocimmune mice. These are genetically-modified rodents that have a human immune system. Regeneron also analyzed human antibodies from COVID-19 survivors. The two most potent ones were selected and were combined into a single drug.
Regeneron says it used the same “rapid response” capabilities and cocktail approach to developing REGN-EB3. That’s a triple antibody treatment for Ebola that’s currently in regulatory review at the FDA. CNN notes that the Ebola treatment worked so well that its clinical trial was stopped early in August 2019. The drug was better at saving lives than any other therapies, and the FDA will make a decision by October.
The first two trials of Regeneron’s new coronavirus drug will look at whether REGN-COV2 works as a treatment for hospitalized and non-hospitalized patients. The pharmaceutical company will then study the drug on uninfected people in groups that are at high risk of exposure, and in uninfected people with close exposure to a COVID-19 patient.