Toronto-based Edesa Biotech (NASDAQ:EDSA) is moving ahead with its COVID-19 drug candidate on a global scale. The company took the stock market by storm on July 30th when it announced the filing of an investigational new drug (IND) application for a phase 2/3 study of EB05, a potential treatment for hospitalized coronavirus patients.
The IND filing with the U.S. Food & Drug Administration (FDA) effectively seeks approval to initiate a late stage clinical study of the investigational drug in the United States. Edesa has already received expedited approval to begin a phase 2/3 study in Canada where it is trying to secure government grants to accelerate the site selection and patient enrollment processes.
EB05 is an experimental monoclonal antibody that Edesa believes may be able to regulate the overactive immune response associated with acute respiratory distress syndrome (ARDS). According to the U.S. Centers for Disease Control (CDC), ARDS develops in 20% to 42% of hospitalized COVID-19 patients and is the leading cause of death among all COVID-19 patients. Before the COVID-19 outbreak, ARDS accounted for 10% of ICU admissions globally representing over 3 million patients.
COVID-19 drug candidate has been shown to stabilize breathing
Edesa’s COVID-19 treatment ambitions are based on previous clinical data that suggests modulating the TLR4 signaling pathway can reduce the number of ICU patients and decrease the need for mechanical ventilation. The EB05 drug candidate works by inhibiting toll-like receptor 4 (TLR4) signaling, an important mediator of inflammation responsible for acute lung injury. It has been previously been shown to be activated by the SARS-CoV1 and influenza viruses.
EBO5’s safety and tolerability has been demonstrated in over 120 patients. It has also been shown to resolve fever and stabilize heart rates and breathing rates.
CEO Dr. Par Nijhawan stated, “The submission of the IND for EB05 in COVID-19 patients marks a key step in our plans to extend our planned phase 2/3 study. We have received positive interest from key opinion leaders regarding our proposed clinical trial and are communicating with hospitals across the country regarding our protocol.”
If approved, the phase 2/3 study would be a multi-location, randomized study to evaluate the efficacy and safety of EB05 in hospitalized adult COVID-19 patients who have or are at risk of developing ARDS. Edesa plans to enroll as many as 450 patients in the first phase of the trial. The patients would receive either an intravenous infusion of a single EB05 dose or a placebo.
The company also noted that if the investigational drug shows promising results based on phase 2 data, its protocol permits the enrollment of additional patients for a pivotal phase 3 study.
Edesa is a Canadian biopharmaceutical company that has a subsidiary in Southern California. It develops treatments for inflammatory and immune-related diseases. Its main product candidate is EB01, a non-steroidal anti-inflammatory molecule designed to treat chronic allergic contact dermatitis. Given the current global health emergency, Edesa has made the EB05 treatment for moderate to severe COVID-19 patients its main priority.
Shares of Edesa Biotech surged 82% on July 30th to $9.45. The company is scheduled to report second quarter financial performance on August 12th.