Study: Mortality rate halved
Cancer drug effectively prevents Covid deaths
04/14/2022, 5:27 p.m.
After nearly two and a half years of the pandemic, people are still dying from coronavirus infection. A new drug gives hope. A phase III study was so successful that it was abandoned. The reason: The product should be on the market as soon as possible.
Since the start of 2020, the coronavirus has claimed more than six million lives worldwide. Although the damage the pathogen can cause has now been greatly 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. The first results of a phase III clinical study conducted by the American pharmaceutical company Veru give hope that this may change.
The drug Sabizabulin, which was developed for the treatment of cancer, has apparently significantly reduced the death rate in patients with severe Covid-19. The manufacturer announced that the study had been terminated prematurely after an interim evaluation and that rapid emergency approval was sought. If a new drug proves to be very effective in clinical tests, according to “Spiegel”, it may be unethical to refuse it to patients in the placebo group or outside the study.
Data from 150 patients were evaluated. They had been given nine milligrams of the active ingredient daily for up to 21 days. Of the 52 patients who were treated as usual and who also received a placebo, almost half (45%) died within 60 days. In contrast, the mortality rate among the 98 Covid 19 patients who were treated regularly and additionally with the test drug Sabizabulin was 20%. This corresponds to a relative reduction in the mortality rate of 55%. According to the company, problematic side effects have occurred not standing.
Prepared for a possible autumn wave
In view of these results, the management of the study recommended the early termination of the study last Friday. According to Veru, a meeting is scheduled with the US Food & Drug Administration (FDA) to discuss next steps, including filing for emergency use authorization. The manufacturer received “Fast Track” status for sabizabulin in January 2022, which aims to speed up the approval process. According to the company, it has already expanded manufacturing processes to ensure commercial drug supply 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 mainly based on the use of steroids, which block the inflammatory reaction. The antivirals remdesivir, paxlovid and molnupiravir are effective only in the early stages of the disease.
Veru also evokes the upcoming fall and winter. Then there could be a wave of spread, with possible new variants that bring new challenges, said Alan Skolnick, who is overseeing the study, according to the press release. “With the results of the phase III study, we have a treatment option for the sickest Covid-19 patients in hospital.”