As COVID-19 continues its destructive path as the most formidable global pandemic in a century, pharmaceutical companies around the globe are racing to develop drug treatments to mitigate the damage. Edesa Biotech, Inc., headquartered in Markham, Ont., is on the frontlines of that fight. Edesa has a monoclonal antibody designed to treat acute respiratory distress system (ARDS), the leading cause of death for patients with COVID-19. “Given how COVID-19 changed the world overnight, and how severe the disease has been, we decided to prioritize our ARDS project to see if we can help patients in the near future,” says Dr. Par Nijhawan, chief executive officer of Edesa, which he founded in 2015 ARDS is a common condition that affects three million patients a year around the world.
It can impact all age groups and results from multiple potential triggers, including viral, bacterial or chemical. Even prior to COVID-19, ARDS accounted for about ten per cent of all ICU beds in the world.During the current pandemic, ARDS has occurred in up to 42 per cent of hospitalized COVID-19 patients, and up to 85 per cent of patients in the ICU, according to the U.S. Centers for Disease Control. The syndrome is primarily caused by an exaggerated immune response to the infection. After the virus enters the body, the body naturally tries to defend itself by triggering an immune response, but in severe patients the exaggerated, prolonged response results in dangerous inflammation, damage and fluid build-up in the lungs. “As COVID-19 patients clinically progress towards ARDS, key inflammatory mediators are often increased. As a result, you get increased cell damage, because even though the immune response is trying to prevent the body from getting damaged, the reality is that the inflammation itself is causing most of the damage,” Dr. Nijhawan explains.
Edesa’s experimental therapy, which targets and inhibits toll-like receptor 4 (TLR4), is intended to suppress this inflammation by blocking the initiation of a key pathway implicated in acute lung injury. Edesa has filed a Clinical Trial Application with Health Canada, which has approved the Phase 2/Phase 3 study. Edesa has also completed the manufacturing/formulation of the drug product to be used in the study.“Our product candidate has already been used in humans and has demonstrated a favourable safety profile. We are looking to getting into clinical trials very shortly and hopefully have an approvable product in the near term,” says Dr. Nijhawan.Ultimately, he believes that focusing on the prevention or treatment of ARDS can lessen the worry about COVID mutations and could also help allow economies to be safely opened up with the assurance that a therapy is available for somebody with even the most severe reaction.“We can potentially take away the biggest fear factor. Especially with COVID being so rampant in the U.S, we feel it will make a difference.” Dr. Nijhawan adds.
Source: BIOTECanada, Insights Fall 2020.