We may have two vaccines and multiple therapeutics cleared for emergency use, but the battle against COVID-19 is far from over.
“We’re probably not even through the first inning of what we’re going to learn here,” said Wendy Holman, CEO of Ridgeback Biotherapeutics, which is working with Merck & Co. on an antiviral drug against COVID-19. Holman spoke during a Fierce JPM Week panel on COVID-19 therapeutics that aired Monday.
In the early days of the pandemic, doctors threw everything they could at the virus, including steroids and approved anti-inflammatory drugs like Roche’s Actemra, simply because there were no options specifically for COVID-19.
“Now, with more time, I think what we’re seeing is the emergence of real customized drugs that are highly focused on SARS-CoV-2,” said Ann Leen, Ph.D., chief scientific officer of AlloVir, which is developing off-the-shelf T-cell therapies to combat viruses, including the one that causes COVID-19.
Building an arsenal of multiple drugs that work in different ways is important, because COVID-19 is a multifaceted illness that affects different people in different ways, the panelists said.
“We don’t fully understand the different aspects of the disease, and also beyond the immediate impacts, but longer-term impacts that we are now seeing as people are recovering and taking a long time to recover,” said Julie Kim, president of the plasma-derived business unit at Takeda. Takeda is part of the CoVIg-19 Plasma Alliance, a group of companies in the plasma industry working on a single, unbranded plasma-based treatment for COVID-19.
“And we will see over time what it becomes and how it changes, so there will never be a silver bullet, a one-size-fits-all,” Holman said. “It’s important to have multiple shots on goal and potentially, combination therapy.”
Over the course of the COVID-19 pandemic, researchers and drug developers have learned more about how the virus afflicts different people and which approaches might work best at different stages of disease.
“We learned about things like the importance of the stage of the disease, the severity of the disease and, as was mentioned earlier, we’re increasingly understanding the importance of recovery and longer-term considerations about the impact of the virus over time,” said Levi Garraway, M.D., Ph.D., chief medical officer and president, head of global product development, at Roche and Genentech.
“I think that’s all-important because it feeds into how we approach therapeutics and the potential utility of different modalities or combinations,” he said.
The panelists agreed that how treatments are tested is just as important as which treatments get tested.
“Although there have been many, many types of clinical studies in COVID-19, unfortunately, a large percentage of them have been designed in a way that it’s hard to know what you could learn from them,” Garraway said. “Either they’re single-arm studies, or observational studies or kind of small studies.”
But that has changed over time, Garraway and Kim noted.
“Early on, there were individual trials, and, now, you see more platform trials where companies are testing their products, their potential candidates in protocols that have been aligned, which also eases the burden on the healthcare system and the regulatory agencies,” Kim said.
In developing treatments and vaccines for COVID-19, drug developers have learned just how quickly they can mobilize against a new disease.
“It’s been such a collaborative relationship working with the FDA to move through new drugs into clinical trials so rapidly. I can speak from the perspective of starting to develop this drug at the beginning of 2020 and being in clinical trials at the end of the year—this is a really fast-moving process now,” Leen said.
“There’s no question that there are going to be many ways in which we, as an industry, conduct clinical trials that are forever changed … for the better,” Garraway said.
It’s not just discovering that processes that used to take weeks could actually take days or hours. It’s also getting people who don’t usually participate in clinical trials to get involved. Because COVID-19 disproportionately affects communities of color, at least in the U.S., drug developers have “learned on the fly” how to carry out trials in those historically underrepresented groups, Garraway said.
“Those are the kinds of learnings that will help us be better at doing clinical trials in populations like this for other medicines going forward,” he said. “If there’s a silver lining, there are a lot of learnings about how we can develop our medicines, test our hypotheses, not just efficiently, but in the broadest set of populations possible.”