Veru shares climbed double-digit to new highs on Monday after the oncology biopharmaceutical company released positive data on a cancer drug being studied to fight Covid-19.
The Miami-based company, which develops breast and prostate cancer drugs, announced that prostate cancer treatment in a Phase 2 clinical trial in hospital patients with acute respiratory distress syndrome caused by Covid-19 had positive results in terms of efficacy and safety led.
The oral drug VERU-111 showed an 82% reduction in deaths or respiratory failure compared to patients given a placebo almost 30 days after treatment, Veru said.
Dr. Mitchell Steiner, CEO of Veru, told CNBC’s Jim Cramer that the cancer drug can have both anti-inflammatory and antiviral effects against the sometimes fatal respiratory disease.
“We were able to show some really tough endpoints,” he said in a Mad Money interview. “For example, a hard endpoint is death. So we saw a reduction in death from 30% in the placebo arm to 5.3% in the treatment arm. As you mentioned, this is an 82% reduction.”
Veru is in line with the U.S. Food and Drug Administration to begin a Phase 3 clinical trial to evaluate the drug’s effects on people with severe cases of Covid-19. It is expected that around 200 hospitalized patients and at high risk for acute respiratory distress syndrome will participate in the next study study.
The phase 2 study included 40 patients and was conducted at five locations in the United States
Veru hopes to start the next clinical phase in April and complete the study in the fourth quarter of this year. The company said it would seek funding from the US Department of Health’s Biomedical Advanced Research and Development Authority to meet US needs should the FDA approve the drug for use.
“We think if we can start in April and finish by the end of the year it will be record time and give everyone the comfort that we have something here that has the robustness needed to treat patients who are the sickest and try. ” Fend off death and respiratory failure, “said Steiner.
Veru shares rose nearly 28% on the day of trading, closing at a record $ 13.92 on a valuation of $ 1 billion.
On Monday evening, the U.S. death from Covid-19 exceeded 464,800.