Clinical-stage biopharmaceutical firm Edesa Biotech Inc. (EDSA:NASDAQ), which is engaged in developing treatments for inflammatory and immune-related diseases, today announced "positive results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients."
The company reported that an independent Data and Safety Monitoring Board (DSMB) tasked with reviewing the initial analysis of the Phase 2 portion of the study requested that the study be preemptively unblinded after it was successful in identifying an important signal between the treatment arms for 28-day mortality and claimed that the study has "met its objective." The DSMB advised additionally that the study should move ahead to the planned Phase 3 confirmatory trial.
Edesa highlighted that in Phase 2 of the study, "The DSMB reported a 28-day death rate of 14.3% (2/14) in the EB05 arm versus 36.8% (7/19) in the placebo arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation)."
The company's CEO Par Nijhawan, M.D. stated, "The unblinded Phase 2 data offer compelling preliminary evidence that EB05 can mediate the overactive immune response associated with acute respiratory distress syndrome, the leading cause of death among COVID-19 patients."
"The strong effect in reducing death in the most critically ill hospitalized patients who have been treated with systemic corticosteroids, including dexamethasone and IL-6 inhibitors, shows the potential life-saving impact of this drug, irrespective of SARS-CoV-2 variant," Dr. Nijhawan added.
The company stated the latest data was gathered from investigational sites in Canada, the U.S. and Colombia. A total of around 360 patients ranging from the ages of 24 to 93, were randomly treated with either a single intravenous infusion of EB05 plus standard of care treatment, or placebo plus standard of care.
The company advised that the data from the DSMB' initial analysis were used simply to evaluate changes in mortality as the first endpoint in the study. Going forward the trial will report on other primary and secondary endpoints.
Edesa said that taking into account the Phase 2 results and comments and recommendations from the DSMB, it plans going forward to focus on critically severe patients and will now place emphasis on patient groups that that have demonstrated the strongest efficacy signals and show the highest potential of rapidly completing enrollment.
The firm mentioned that it intends to submit amendments for the Phase 3 trial protocols with regulators in the U.S., Canada and Colombia and to determine the optimum number of patients for enrollment.
Edesa noted that concurrently, it is now considering moving forward with applications to expedite regulatory review programs in both the U.S. and Canada.
Edesa Biotech's V.P. of Research and Development Blair Gordon, Ph.D. mentioned, "With few meaningful treatment options available for hospitalized patients and clear evidence that the COVID-19 virus is becoming endemic, we are evaluating ways to expedite the next steps in our development and commercialization plans."
The company described EB05 as "an experimental monoclonal antibody that it believes could regulate the overactive and dysfunctional immune response associated with acute respiratory distress syndrome (ARDS).
It has been widely reported that ARDS at present is the leading cause of death in COVID-19 patients worldwide. The firm pointed out that "the U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU."
Edesa Biotech is a clinical-stage biopharmaceutical firm headquartered in Markham, Ont., Canada with offices at a subsidiary company in the U.S. in southern Calif. The firm concentrates its efforts on development of treatments for unmet inflammatory and immune-related diseases, including alternatives to topical steroids. The company's leading product candidates include EB05, a monoclonal antibody therapy being developed for treating ARDS, which is a severe, life-threatening form of respiratory failure and leading cause of death in SARS-CoV-2 patients. Another advanced candidate in the company's development pipeline is a sPLA2 inhibitor, EB01, that is being formulated as a topical treatment for chronic allergic contact dermatitis (ACD).
Edesa Biotech began the day with a market capitalization of around $77.9 million with approximately 13.26 million shares outstanding. EDSA opened 60% higher today at $9.45 (+$3.57, +60.71%) over Friday's $5.88 closing price and reached a new 52-week high intraday price this afternoon of $11.16. The stock has traded today between $7.47 to $11.16 per share and closed at $11.92 (+$6.04, +102.72%).
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