Study: Death Rate Cut in Half
Cancer drug effectively prevents Covid deaths
Almost two and a half years into the pandemic, people are still dying from coronavirus infection. A new drug gives hope. A phase III study is so successful that it is abandoned. The reason: the product must be on the market as soon as possible.
Since the beginning of 2020, the coronavirus has claimed more than six million lives worldwide. Although the damage that the pathogen can cause has now been significantly reduced thanks to vaccination and milder variants, Covid-19 remains a life-threatening disease. In Germany, around 300 people still die from or with the virus every day. Initial findings from a phase III clinical study conducted by the US pharmaceutical company Veru give hope that this may change.
The drug Sabizabulin, which was developed for cancer treatment, has apparently significantly reduced the death rate in patients with severe covid-19. The manufacturer announced that the study was terminated prematurely after an interim evaluation and that an emergency fast-track approval was being sought. If a new drug proves to be highly effective in clinical trials, according to Spiegel, it may be unethical to deny it to patients in the placebo group or outside the study.
Data from 150 patients were evaluated. They had received nine milligrams of the active ingredient daily for up to 21 days. Of the 52 patients who were treated as usual and also received a placebo, nearly half (45 percent) died within 60 days. In contrast, the mortality rate among the 98 covid-19 patients who were treated regularly and additionally with the tested drug Sabizabulin was 20 percent. This corresponds to a relative reduction in mortality rate of 55 percent. According to the company, troublesome side effects occurred. not up.
Prepared for a possible fall wave
In view of these results, the study leadership recommended early termination of the study last Friday. According to Veru, a meeting with the US Food and Drug Administration (FDA) is planned to discuss next steps, including filing an emergency use authorization application. The manufacturer received “Fast Track” status for sabizabulin in January 2022, which is intended to speed up the approval process. According to the company, it has already expanded manufacturing processes to ensure the commercial supply of drugs in the event of FDA approval.
A publication on the study that has been verified by independent experts is not yet available. However, if the results are confirmed, sabizabulin would be an important addition to current treatment options. In the case of moderately severe and severe diseases, these are currently essentially based on the use of steroids, which block the inflammatory reaction. The antivirals remdesivir, paxlovid, and molnupiravir are only effective in the early stages of the disease.
Veru also points to the upcoming fall and winter. Then there could be a wave of spread, with possible new variants bringing new challenges, said Alan Skolnick, who is overseeing the study, according to the news release. “With the results of the phase III study, we have a treatment option for the sickest Covid-19 patients in the hospital.”