A drug initially developed in hopes of treating cancer patients could significantly cut the risk of death among hospitalizedpatients who are at high risk of severe disease, results published on Wednesday suggest.
The findings on the drug, called sabizabulin, were first announced in early April by drugmaker Veru, which submitted an emergency use authorization request last month. If the Food and Drug Administration signs off, it could add another option to the stable of drugs doctors turn to for treating hospitalized cases.
"We have battled this pandemic for two and a half years now, and we are still in desperate need for an effective treatment like sabizabulin to significantly reduce deaths in hospitalized COVID-19 patients," Dr. Alan Skolnick, the study's principal investigator, said in Veru's release touting the publication of results in the journal NEJM Evidence.
Veru gave the drug to 130 hospitalized adults who had an underlying condition that put them at risk of severe COVID-19, including having a compromised immune system or being 65 or older.
In the study, 45% of placebo recipients who got "standard of care" treatment, without sabizabulin, died. By comparison, 20% of the patients who also got Veru's capsules on top of their other typically prescribed medications passed away.
This "overwhelming efficacy" — appearing to halve the risk of death among these at-risk patients — drove Veru to stop its trial early, the company said, and seek the FDA's authorization after the regulator told them they had sufficient safety and efficacy data to support the request.
Sabizabulin's benefit appears to outpace the smaller mortality reductions seen in trials of other commonly deployed treatments in patients hospitalized for COVID-19 who are receiving supplemental oxygen, like the steroid dexamethasone or the antiviral remdesivir.
However, many of those studies tested the drugs in more patients than Veru's relatively small clinical trial. The share of patients in the placebo group who died also appears worse than in other trials, which can risk exaggerating sabizabulin's effect.
Other COVID-19 treatments, like Pfizer's or Merck's Lagevrio, are only authorized to treat people before they end up in the hospital.
Veru says it has already "scaled up manufacturing" of the drug in hopes of being able to produce enough of the capsules to meet demand if it is authorized.
Patients took the 9 mg pill once per day in Veru's trial, for up to 21 days, until they were discharged from the hospital.
Similar to the way it aims to curb the growth of tumors, Veru says sabizabulin could work also to disrupt the spread of SARS-CoV-2 in the body as well as to help tame the sometimes-fatal immune response the virus can trigger.
Veru's findings, which spanned the Delta variant and early Omicron variant waves through January 2022, come as the U.S. is facing yet another wave of COVID-19 hospitalizations from new subvariants of the virus.
The BA.4 and BA.5 sublineages of Omicron, which appear to spread faster and evade the body's immune defenses better than previous strains, together are now estimated to make up more than 7 in 10 new infections in the U.S.
Several regions reported renewed accelerations in the pace of new COVID-19 hospitalizations ahead of the Fourth of July holiday weekend. And after a months-long slowdown, the pace of new COVID-19 deaths has remained plateaued for months — averaging around 300 per day since April.
"Although we are not at that very fulminant stage that we were at several months ago, where we were having 800- to 900,000 infections a day and 3,000 deaths per day, that was horrible then, but that doesn't mean it's good now," Dr. Anthony Fauci, the president's chief medical adviser, told the Australian talk show "3AW Drive" this week.
"Still we have a consistent 300-plus deaths per day. And we really got to get below 100,000 infections a day," added Fauci.