Veru shares surged double digits to new highs Monday after the oncology biopharmaceutical company released positive data about a cancer drug being studied to help fight Covid-19.
The Miami-based company, which develops drugs for breast and prostate cancer, disclosed that a prostate cancer treatment yielded positive efficacy and safety results in a Phase 2 clinical trial in hospitalized patients suffering from acute respiratory distress syndrome caused by Covid-19.
The oral drug, called VERU-111, showed an 82% reduction in deaths or respiratory failure almost 30 days after treatment, compared to patients receiving a placebo, Veru announced.
Dr. Mitchell Steiner, CEO of Veru, told CNBC’s Jim Cramer that the cancer medicine can serve as both an anti-inflammatory and antiviral against the sometimes deadly respiratory disease.
“We were able to show some real hard endpoints,” he said in a “Mad Money” interview. “For example, a hard endpoint is death and so we showed a reduction in death from 30% in the placebo arm to 5.3% in the treatment arm. So that, as you mentioned, that’s a reduction of 82%.”
Veru is in line to meet with the U.S. Food and Drug Administration as part of its efforts to begin a Phase 3 clinical trial to study the drug’s impact on individuals with severe cases of Covid-19. About 200 hospitalized patients and high risk for acute respiratory distress syndrome are expected to participate in the next trial study.
The Phase 2 trial included 40 patients and was carried out in five sites across the U.S.
Veru hopes to begin the next clinical stage in April and to complete the trial in the fourth quarter of this year. The company said it would seek funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to supply needs in the U.S., should the FDA approve the drug for usage.
“We think if we can get started in April and be done by year-end, that’s record time and gives everybody the comfort that we have something here that’s got the robustness that will be required to go after patients that are the sickest and try to stave off death and respiratory failure,” Steiner said.
Veru stock jumped nearly 28% during the trading day, closing at a record $13.92 for a $1 billion valuation.
As of Monday evening, U.S. deaths of Covid-19 exceeded 464,800.
