Edesa Biotech Inc. (NASDAQ: EDSA) joins the list of COVID-19 stocks, as the company is making headway with regulatory agencies for its late-stage study. Investors were quick to give this firm the coronavirus bump, more than doubling shares early on Thursday.
In terms of the specifics, the company filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients.
Recently, the company received expedited approval to begin the Phase 2/3 study in Canada, and it is seeking government grants to accelerate site selection and initiate patient enrollment.
Some quick background: EB05 is an experimental monoclonal antibody that seeks to regulate the overactive immune response associated with acute respiratory distress syndrome (ARDS), which is the leading cause of death in COVID-19 patients. Essentially, this drug will be looking to compete with Gilead’s COVID-19 treatment, remdesivir.
Based on previous clinical data, the company believes that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.
The safety and tolerability of EB05 has been demonstrated in more than 120 subjects. The antibody therapy has demonstrated an ability to resolve fever as well as stabilize heart rates and breathing rates in test subjects who were injected with a potent inducer of acute systemic inflammation.
The company plans to enroll up to 450 patients in the first phase of the trial. Patients will be infused intravenously with a single dose of EB05 or placebo. If the drug treatment demonstrates promising results at the Phase 2 readout, the protocol allows for enrollment to continue as a pivotal Phase 3 study.
Edesa stock traded up about 170% to $14.13 on Thursday, in a 52-week range of $1.58 to $10.00. The consensus price target is $16.00.
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