The first experimental drug developed to fight cancer has cut the risk of death for people hospitalized in Covid by half. study It was released on Wednesday.
The drug Savizabrin appeared to be more effective than other drugs approved for critically ill Covid patients.Veru, the Miami company that developed the drug Apply To the Food and Drug Administration for an emergency permit for its use. Experts say it could add new weapons to the modest weapons available to inpatients.
“This is very impressive,” said Dr. Iran Schwartz, an infectious disease expert at the University of Alberta who was not involved in the study. “There are few treatments for patients with serious illnesses that improve mortality, but alternative treatments that can further reduce mortality are welcome.”
However, Dr. Schwartz warned that the trial was relatively small and that only 134 patients were given the drug. “Overall, I think this is very exciting, but we welcome larger and independent confirmatory studies,” he said.
Sabizabulin blocks cells from building microtubules. Microtubules are important molecular cables that shuttle substances from one part of the cell to another.
The medicine is originally Researchers at the University of Tennessee have developed to fight cancer because rapidly growing tumor cells rely on microtubules to grow rapidly.
Two years ago, Vel’s researchers tried Savizabrin in Covid. They suspected that the drug might prevent the virus from replicating. This relies on the microtubule network to assemble new virus fragments.
They also hypothesized that the drug would help Covid patients fight potentially life-threatening lung inflammation. This immune response begins when the cell recognizes that it is infected and releases an alarm signal protein to its surroundings. The cell needs to push the alarm molecule along the microtubules to make a word.
The company was already looking for volunteers in the hospital for Covid. To be eligible for the study, the patient had to receive oxygen or rely on a ventilator. They also needed to be at high risk of dying from Covid, along with risk factors such as high blood pressure, old age and obesity.
Patients were able to receive other treatments that have been shown to be effective in saving the lives of hospitalized Covid patients at the same time. For example, a steroid called dexamethasone reduces the risk of death by a third.
In the latest trial, 134 volunteers received savizabrin and 70 placebos. In 60 days, the mortality rates of the two groups were very different. Only 20.2% of the new drug group died, compared to 45.1% of the placebo group. The difference was translated into a 55.2 percent reduction in mortality risk.
Dr. David Boulware, an infectious disease expert at the University of Minnesota, warned that numerous deaths in the placebo group could be a sign that the study was too small to draw firm conclusions.
“I think the 45% mortality rate in the control group is pretty high for me,” he said.
In contrast, Arthritis treatment drug test A researcher called baricitinib administered the drug to 515 Covid patients and 518 to placebo. Only 7.8 percent of the placebo group died.
Many antiviral drugs have proven effective in keeping Covid patients away from the hospital, but only if they are given in the early stages of the disease. For example, Paxlovid can reduce the risk of hospitalization for unvaccinated people by about 90% with Covid risk factors.
However, these medications are ineffective for moderate to severe Covid inpatients. It doesn’t suppress the reaction of the runaway immune system, it just blocks the virus.
For inpatients, the doctor Fewer medicines to choose.. In addition to dexamethasone and baricitinib, another anti-inflammatory drug called tocilizumab has been shown to help.
When Veru first released its results in April, the company said it had stopped the trial early because an independent advisory board determined that the benefits of Savizabrin were already clear from the data. They decided that it was unethical to continue to receive placebo in some patients.
Dr. Boulware recognized the ethical demands of the situation, but predicted that if the trial was prolonged, the benefits of the drug might appear to be more modest.
“Early discontinued trials routinely overestimate their effectiveness,” he said.
Dr. Boulware said the Covid drug molnupiravir initially seemed to reduce the risk of hospitalization with Covid by 50%.But that number drop In the final analysis it will be 30%.
He predicted a similar fate for Savizabrin. “I’m skeptical that the effect is 55 percent,” said Dr. Boulware.
