Edesa Biotech Shares Rise After Positive Phase 2 Data of Its Monoclonal Antibody in Hospitalized COVID-19 Patients

Sep 20, 2021 By MarketDepth

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Edesa Biotech, Inc. (NASDAQ: EDSA) stock jumped more than 38% after the clinical-stage biopharmaceutical company 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.

Significant Signal Recognized

The company reported that an independent Data and Safety Monitoring Board (DSMB) informed the company that during its initial analysis of the Phase 2 portion of the study they recognized a significant signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded. While the Phase 2 portion was mainly intended to refine patient stratification and statistical powering for the Phase 3 study, the DSMB determined that “a clinically important efficacy signal” was detected and that the study has “met its objective.” The DSMB further suggested continuation of the study into a Phase 3 confirmatory trial.

Compelling Evidence

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said that 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. 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.”

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech