An experimental drug halved the death rate among critically ill Covid patients who were receiving supplemental oxygen and were at high risk for serious lung disease and death, the drug's developer announced on Monday.
There is a need for new treatments for critically ill patients. Paxlovid, made by Pfizer, is meant for patients with mild or moderate disease. The treatments given to hospitalized patients have shown limited effectiveness.
Independent safety monitors recommended stopping the new drug, sabizabulin, early because it reduced deaths among hospitalized Covid-19 patients so drastically. The trial was stopped on Friday.
The results of that trial have not been reviewed or published. The findings were announced at a news conference. The company's stock went up in trading on Monday.
Half of the trial participants died within 60 days of receiving a placebo or dummy pill. The death rate was 20 percent among the 98 people who received the drug. For up to 21 days, the drug was given once a day.
The first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients isabizabulin.
Most Covid restrictions have been lifted in the United States, but cases, hospitalizations and deaths around the world continue to be high. Surges will follow the emergence of new variant.
Over a million Americans have died of Covid, and there are still many.
The drug was granted fast-track status by the FDA. It is intended that the designation will prompt faster development and review of new treatments that address unmet medical needs and target serious or life threatening conditions.
The company plans to apply for emergency-use authorization for sabizabulin later this month, according to Dr. Steiner. The F.D.A. did not confirm, deny or comment on pending applications.
The company said there were no safety concerns related to the drug.
Despite it being two and a half years into the battle, we are still working hard to get highly effective drugs into the mix to treat this specific population of patients.
Dr. Gordon said he was eager to see more detailed analyses. More data was still being analyzed on Monday, including the proportion of patients without respiratory failure, the number of days they spent in intensive care, the length of their hospital stay and how long they were on mechanical ventilation.
No drug works for everyone, according to Dr. Gordon.
All standard care and treatment was given to patients on both arms of the trial. The participants were in the United States, Brazil, Argentina, Mexico, Colombia and Bulgaria, and they had been exposed to both the Delta and Omicron variant. The drug is effective regardless of the variant type, according to company officials.
The 9-milligram dose of sabizabulin was taken once a day. It doesn't need to be refrigerated and can be given by mouth or opened up so that the contents can be added to a feeding tube.
Making the drug accessible to patients in the United States will be simpler than making it available to outpatients because it is only intended for hospitalized patients.
The coronaviruses can get from Point A to Point by disrupting the transport of the microtubules in cells.
He said that the disruption interfered with the movement of the body's own cytokines.
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