There is a pressing need for new treatments for critically ill patients. Drugs like Paxlovid, made by Pfizer, are aimed primarily at patients who have mild or moderate disease. Other treatments administered to hospitalised patients in serious condition have shown limited effectiveness.
The new drug, sabizabulin, reduced deaths among hospitalised COVID-19 patients so drastically in a clinical trial that independent safety monitors recommended stopping it early, officials at Veru Inc., the drug’s maker, said. The trial was halted Friday.
The results of that trial have not been reviewed by outside experts or published in a medical journal. Veru announced the findings at an early-morning news conference. The company’s stock soared in trading Monday following the announcement.
About half of the 52 trial participants given a placebo or dummy pill along with regular care died within 60 days, an indicator of how very sick they were. But the death rate was 20% among the 98 participants who received sabizabulin, who were just as ill. The drug was given once a day for up to 21 days.
“Sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalised patients,” Dr Mitchell Steiner, CEO of Veru, said. “This represents a big step forward.”
Most COVID restrictions have been lifted in the United States after declining case numbers, but cases, hospitalisations and deaths around the world continue to be high, Steiner added. New variants are bound to emerge, and surges will follow.
Close to 1 million Americans have died of COVID, and there are still 570 fatalities every day on average.
The drug was granted so-called fast-track status by the Food and Drug Administration in January, Steiner said. The designation is intended to prompt faster development and review of new treatments that address unmet medical needs and target serious or life-threatening conditions.
Steiner said the company plans to meet with the agency later this month and will be applying for emergency-use authorisation for sabizabulin. An FDA spokesperson declined to comment, saying the agency did not confirm, deny or comment on pending applications.
No safety concerns related to the drug were identified in the course of the clinical trial, company officials said.
“Despite it being 2 1/2 years into the battle, we are still working hard to get highly effective drugs into the mix to treat this specific population of patients, and this is a fairly dramatic improvement in 60-day mortality,” said Dr Michael Gordon, one of the trial investigators and chief medical officer at HonorHealth Research and Innovation Institute in Scottsdale, Arizona.
But Gordon leavened his optimism with caution, saying he was eager to see more detailed analyses. Additional data were still being analysed Monday, including the proportion of treated 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 everybody,” Gordon said. “The benefit that was seen is mortality — who is living and who is dying — not who is getting off oxygen, though I anticipate we will see improvement in other parameters, too.”
Patients on both arms of the multicenter trial received all standard care and treatment. The participants were in the United States, Brazil, Argentina, Mexico, Colombia and Bulgaria, and they had been infected with both the delta and omicron variants. The drug is effective regardless of the variant type, Gordon and company officials said.
Sabizabulin was given in a 9-milligram dose in a capsule that was taken once a day. It doesn’t require refrigeration, and the capsule can be given by mouth or opened up so that the contents can be added to a feeding tube.
The drug is intended only for hospitalised patients at this point, so making it accessible to patients in the United States will be simpler than making it available to outpatients, which requires distributing it to pharmacies and educating general doctors about its use.
Sabizabulin works by disrupting the transport of the coronavirus through microtubules in cells. “It disrupts these ‘highways’ and breaks them down, so the virus can’t get from Point A to Point B,” Steiner said.
The disruption also interferes with the movement of the body’s own cytokines, which works to tamp down inflammation, he added.
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