Edesa Biotech Inc (NASDAQ: EDSA) stock was up 70% premarket after releasing excellent results from its phase 2 clinical trial of its monoclonal antibody candidate EB05 as a single-dose treatment for hospitalized COVID-19 patients.
The study was preemptively unblinded after an independent Data and Safety Monitoring Board (DSMB) noted that the trial data had demonstrated “a clinically important efficacy signal”, hence, meeting its initial objective.
Investors cheered the move,w which clears the study to proceed to phase 3 confirmatory studies after which the drug could be approved for emergency use given its effectiveness.
The independent board discovered 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).
From the above results, we can understand why the independent board chose to unblind the study given that the results were pertaining to actual deaths and measured by a death rate. The high effectiveness of EB05 compared to the placebo also contributed to the decision.
Edesa also reported that EB05 was well-tolerated among participants with the results being consistent with the observed safety profile. There was also a separate group of patients whose mortality signals fell drastically within the 28 days, which warrants further analysis.
Dr Par Nijhawan, MD, Edesa Biotech’s CEO, said: “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,”
Adding:
“On behalf of Edesa, I'd like to express our continuing gratitude to the patients, their families and healthcare workers participating in the study as well as our partners for helping facilitate the rapid completion of this first leg of the study.”
Edesa Biotech stock price.
Edesa Biotech stock was up 70.06% to trade at $10, rising from Friday’s closing price of $5.88.
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