Edesa Biotech, Inc. (NASDAQ: EDSA) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research and development of innovative treatments for inflammation and immune-related illnesses. Shares of the biopharma company are soaring 39% through early trading on Monday, September 20, 2021. Over the past three months, Edesa Biotech has seen average daily volume of 105,160 shares. However, volume of 44.5 million shares or dollar volume of $371.58 million, has already exchanged hands through early trading on Monday.
Shares of Edesa Biotech are gaining after the company reported positive Phase 2 clinical study results from its monoclonal antibody candidate, EB05, as a single-dose treatment for patients hospitalized with COVID-19. The independent Data and Safety Monitoring Board (DSMB) reported the 28-day death rate with EB05 to be 14.2% (2/14) compared to a 36.8% (7/19) death rate for the placebo group. Survival analysis shows that EB05 combined with standard care led to a 68.5% reduction is death risk compared to the placebo group, over a 28-day period.
The Phase 2 study was comprised of data from 360 patients, aged 24 to 93 years old. The test patients were located in the United States, Canada and Colombia. Patients in the study were treated with a single infusion of with EB05 or a placebo in a randomized study.
Most importantly, EB05 data from its Phase 2 study shows the monoclonal antibody treatment is generally well-tolerated. The Data and Safety Monitoring Board says they have also found another patient group that reported significant mortality reduction using the candidate treatment. Further reviewing and testing is needed to confirm the second group data.
“The strong effect in reducing death in the most critically ill hospitalized patients who have been treated with systemic corticosteroids, including dexamethasone, and IL-6 inhibitors, shows the potential life-saving impact of this drug, irrespective of SARS-CoV-2 variant,” he said. “On behalf of Edesa, I’d like to express our continuing gratitude to the patients, their families and healthcare workers participating in the study as well as our partners for helping facilitate the rapid completion of this first leg of the study.”
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