New drug reduces deaths among patients with severe Covid

An experimental drug halved the death rate among critically ill Covid-19 patients who were receiving oxygen and were at high risk of severe lung disease and death. The announcement was made on Monday (11) by the manufacturer of the drug.

There is an urgent need for new treatments for critically ill patients. Medicines like Paxlovid, made by Pfizer, are primarily aimed at patients with mild to moderate Covid. Other treatments given to people hospitalized with a serious condition have shown limited effectiveness.

In a clinical trial of patients hospitalized with Covid, the new drug, sabizabulin, led to such a dramatic reduction in deaths that independent safety monitors recommended that its use be stopped ahead of schedule, representatives from Veru Inc, the drug’s maker, said. The rehearsal was suspended last Friday (8).

The trial results have not yet been peer-reviewed or published in a medical journal. Veru announced the results at a press conference Monday morning. After the announcement, the company’s shares soared on the stock markets.

About half of the 52 trial participants who received a placebo in addition to usual care died within 60 days, an indication of how seriously ill they were. But among the 98 participants who received sabizabulin and were in similarly serious condition, the death rate was only 20%. The drug was given once a day for up to 21 days.

“Sabizabulin is the first drug to deliver a clinically and statistically significant reduction in inpatient mortality,” said Veru CEO Mitchell Steiner. “It’s a very important advance.”

Most restrictions due to Covid have been lifted in the United States due to the drop in the number of cases, but, Steiner said, around the world cases, hospitalizations and deaths remain high. New variants must emerge and be followed by new outbreaks.

Nearly a million Americans have died from Covid, and there are still 570 deaths a day on average.

Steiner said the Food and Drug Administration (FDA) gave sabizabulin so-called “fast-track” status in January. The designation is intended to encourage faster development and review of new treatments to address unmet medical needs and for serious or life-threatening conditions.

Steiner said the company plans to meet with the FDA this month and apply for emergency use authorization for sabizabulin. An FDA representative declined to comment, saying the agency does not confirm, deny or comment on pending requests.

According to Veru representatives, no drug-related safety concerns were identified during the clinical trial.

“Although this battle started two and a half years ago, we are still working intensively to develop effective drugs to treat this specific patient population, and what we saw in 60 days was a dramatic reduction in mortality,” commented Michael Gordon, one of the clinical trial investigators and medical director of the HonorHealth Institute for Research and Innovation in Scottsdale, Arizona.

But he tempered his optimism with caution, saying he wants to see more detailed analysis. Additional data was still being analyzed on Monday, including the share of patients treated without respiratory failure, the number of days they spent in the ICU, the length of their hospital stay and how long they needed mechanical ventilators.

“No one drug works for everyone,” Gordon said. “The benefit seen with this drug was in mortality — that is, who lived and who died — and not who could stop receiving oxygen. But I predict that we will see improvements in other parameters as well.”

All patients in the two groups who participated in the multicenter study received referral treatment and care. Participants were in the United States, Brazil, Argentina, Mexico, Colombia and Bulgaria and were infected with the delta and omicron variants. Gordon and company representatives said the drug is effective regardless of variant.

Sabizabulin was given at a dose of 9 milligrams contained in a capsule that the patient took orally once a day. The capsule does not need to be kept in the fridge. It can be given in the mouth or it can be opened so the contents are added to a feeding tube.

The treatment is only intended for hospitalized patients, at least for now. Therefore, making it available to patients in the United States will be simpler than making it available to outpatients, which would require distributing it to pharmacies and educating general practitioners about its use.

The drug works by interrupting the transport of the coronavirus by microtubules in cells. “It blocks and breaks these ‘roads,’ so the virus can’t get from point A to point B,” Steiner said.

The blockage also interferes with the movement of cytokines in the body, which has the effect of limiting inflammation, he said.

^{Clara’s Translation Allain}