Clinical-stage biopharmaceutical company Edesa Biotech Inc. (EDSA:NASDAQ), which is focused on developing treatments for inflammatory and immune-related diseases, today announced that "it has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, which the company is developing as a potential treatment for moderate to severe COVID-19 patients."
The firm indicated that it a has sufficient EB05 drug product available now and plans to begin the study at up to 30 sites. The company advised that it is also currently seeking government grants to accelerate the commencement and roll out of the study.
The company explained that "EB05 is a monoclonal antibody that has demonstrated the ability to suppress the release of proinflammatory cytokines that are often observed in severe COVID-19 patients and that specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - a key component of the innate immune system and an important mediator of inflammation responsible for acute lung injury that has been shown to be activated during SARS and Influenza infection."
The firm stated that it plans to enroll as many as 355 patients in the first phase of the Phase 2/3 EB05 trial, which is planned to be a multi-location study to evaluate the efficacy and safety of EB05 in moderate to severe adult hospitalized COVID-19 patients.
The company's CEO Dr. Par Nijhawan 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...We greatly appreciate the actions being taken by the government to expedite COVID-19 applications and provide support for clinical studies."
Edesa Biotech is a clinical-stage biopharmaceutical company based in Markham, Ontario, and also has offices in the U.S. located in southern Calif. The firm develops treatments for inflammatory and immune-related diseases particularly those with clear unmet medical needs.
Edesa Biotech started off the day with a market capitalization of around $25.7 million with approximately 8.859 million shares outstanding. EDSA shares opened 140% higher today at $6.97 (+$4.07, +140.34%) over Friday's $2.90 closing price. The stock has traded today between $5.80 and $10.00 per share and is currently trading at $6.17 (+$3.27, +112.76%).
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