A clinical trial of a new medication to treat COVID-19 in people who are hospitalized with the virus was so successful that researchers stopped it early. Key TakeawaysSabizabulin is designed to treat hospitalized patients with severe COVID-19.Clinical trials found it can reduce the risk of death by 55% in patients.The makers of sabizabulin plan to submit an emergency use authorization application to
A clinical trial of a new medication to treat people hospitalized with COVID-19 was so successful that researchers stopped it early.
Researchers shut down a phase 3 trial for the drug, called sabizabulin, last week after they determined that it has the potential to halve the risk of death for people with moderate and severe forms of COVID-19.
They analyzed 210 people hospitalized with COVID-19 who were at high risk for developing acute respiratory distress syndrome (ARDS), a serious complication of the virus. Some were given 9 milligrams of sabizabulin while others were given a placebo. Patients in both groups were given the standard of care, which includes remdesivir, dexamethasone, antibodies, and JAK inhibitors.
The researchers found that those who were treated with sabizabulin were 55% less likely to die than those in the placebo group. The placebo group also had a 45% mortality rate compared to the sabizabulin group, which had a 20% mortality rate.
There were also no clinically relevant issues with safety in the sabizabulin group. As a result, an independent data safety monitoring committee unanimously recommended that researchers end the study early.
Sabizabulin is “a game-changer,” Mitchell Steiner, MD, chairman, president, and CEO of Veru, the company that makes the drug, told Verywell. Steiner said that “getting as many people as we can vaccinated” is important but “we’ve learned that while vaccines help, herd immunity probably doesn’t exist with this kind of virus.”
While there are medications to help lower your risk of being hospitalized, Steiner said it’s important to have additional medications for the treatment of patients who end up severely ill with COVID-19.
Sabizabulin is an anti-viral and anti-inflammatory drug. “The virus causes infection, but triggers an inflammatory response,” Steiner explained. “When you’re getting a cytokine storm, getting an antiviral and anti-inflammatory is important.”
Sabizabulin helps tamp down on an important part of the virus replicating in the body. “When the virus enters the cell, a variety of steps need to occur,” Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, told Verywell. “One of those is that it needs to move within the cell from one compartment to the other. This drug interferes with the process.”
The medication is “very different from everything else out there,” Gary Barnette, PhD, chief scientific officer at Veru, told Verywell. Sabizabulin will work regardless of the COVID-19 variant a person is infected with, Barnette said.
“If additional variants come out in the future, it is expected to be effective because of the mechanism of action of the drug,” he added.
Sabizabulin had impressive results in phase 3 clinical trials and will be up for an emergency use authorization soon. If it’s approved, it will give health care providers one more option for treating people who are severely ill with COVID-19.
Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, told Verywell that sabizabulin is “unique among COVID treatments” in the way that it works.
“This is a promising medication that can significantly impact mortality rates in hospitalized COVID patients,” he added.
Russo agrees. “This is the newest kid on the block. It’s extraordinarily exciting,” he said. When combined with existing treatments, “it provides additional benefit” to severely ill patients, Russo noted.
The study results “also open the door that the next clinical trial may be outpatient,” Russo said. “We have Paxlovid and molnupiravir, but it would be nice to have another oral agent that’s efficacious as well."
Next up for sabizabulin is a conversation with the Food and Drug Administration (FDA) about an application for an emergency use authorization, followed by the actual application. That, Barnette said, should happen “very soon.”
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