Edesa Biotech, Inc. (NASDAQ: EDSA) is a clinical-stage biopharmaceutical company that specializes in treatments for dermatological and gastrointestinal ailments. Shares soared 100% on Monday, June 15, 2020. Over the past three months, Edesa has seen an average daily volume of 64,350 shares. However, on Monday, 55,437,828 shares exchanged hands, equating to $321.5 million in dollar volume.
Shares surged Monday after Edesa announced it has been granted expedited approval by Health Canada for its COVID-19 treatment, EB05, to begin its Phase 2/3 clinical study. Edesa currently has EB05 available and is requesting government grants to speed up the commencement of the study.
Edesa Biotech: EB05 Candidate Seeks to Treat Moderate-t0-Severe COVID-19
In the first phase of the study, Edesa will enroll 355 patients at 30 sites in a double-blind, placebo-controlled trial, testing the effectiveness and safety of EB05 in moderate to severe COVID-19 cases. Enrollment will continue as a Phase 3 study if the desired results are met in the Phase 2 trial. EB05 has previously demonstrated tolerability and safety in over 120 patients.
EB05 is a monoclonal antibody that has previously demonstrated the ability to suppress the release of proinflammatory cytokines in severe COVID-19 cases. Inflammation and damage to the lungs are common in COVID patients due to the immune system being over-active in a process being called a “cytokine storm”. In moderate and severe cases, this could develop into acute respiratory distress syndrome (ARDS) which is the leading cause of death in COVID-19 patients. There is a great need for treatments of ARDS as there are few current treatments besides supplemental oxygen and mechanical ventilation.
Dr. Par Nijhawan, CEO of Edesa, commented, “Health Canada’s expedited review process and subsequent approval of our Clinical Trial Application represents a significant step in developing new drugs that can treat the underlying conditions induced by the SARS-CoV-2 infection.”
COVID-19 Treatment Development Under Close Watch
Edesa is among a rising group of biotech and healthcare companies that are moving ahead with clinical trials hoping to find a suitable treatment or therapy for the novel coronavirus. Notable clinical trials that are being widely-watched include Gilead Sciences’ (NASDAQ: GILD) remdesivir Phase 3 trials, AstraZeneca (NYSE: AZN) and Oxford’s U.K. Phase 2/3 clinical trial, and Moderna’s (NASDAQ: MRNA) mRNA-based vaccine currently in Phase 2 trials.
Overall, biotech and healthcare companies are still a ways off from reaching mass production levels of a potential treatment. However, researchers and experts are hoping some initial therapeutics can be available by the end of 2020 or into early 2021. With coronavirus cases growing once again, researchers know its a continued race against time in order to thwart more death and suffering.
Article By: Andrew Rego