- The stock price of Edesa Biotech Inc (NASDAQ: EDSA) increased by over 60% pre-market. This is why it happened.
The stock price of Edesa Biotech Inc (NASDAQ: EDSA) – a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases – increased by over 60% pre-market. Investors are responding positively to the company announcing 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.
An independent Data and Safety Monitoring Board (DSMB), composed of subject matter experts, informed Edesa Biotech that during its initial analysis of the Phase 2 portion of the study they identified an important signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded. And while the Phase 2 portion was primarily designed to refine patient stratification and statistical powering for the Phase 3 study, the DSMB concluded that “a clinically important efficacy signal” was detected and that the study has “met its objective.” The DSMB also further recommended the continuation of the study into a Phase 3 confirmatory trial.
Among the findings, the DSMB had 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). And Survival Analysis using Cox’s Proportional Hazard Model showed that the patients treated with EB05 plus standard of care had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days (HR: 3.17 placebo vs. EB05; 95% CI: 0.66-15.35; p=0.15). The currently available data indicates that greater than 90% of patients received dexamethasone (or other steroids), more than 45% received both tocilizumab and a steroid.
The results from the Phase 2 analysis also suggests that EB05 has been generally well-tolerated and consistent with the observed safety profile to date. And the DSMB identified another patient group with robust signals for mortality reduction at 28 days and the company plans to review this data as well as the full dataset.
Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said that the unblinded Phase 2 data offered 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 analysis reviewed data from approximately 360 patients, 24 to 93 years of age from investigational sites in the United States, Canada, and Colombia. And participants were treated with a single intravenous infusion of either EB05 plus standard of care treatment, or placebo plus standard of care (randomized 1:1). The DSMB’s initial analysis was limited to the mortality endpoint and a review of other endpoints is ongoing.
Based on the Phase 2 results and guidance from the DSMB, Edesa is planning to focus on patient segments that have demonstrated the strongest efficacy signals and have the greatest potential of rapidly completing enrollment, beginning with critically severe patients. And the company intends to file amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol and set targeted enrollment. Edesa is also evaluating opportunities to apply for expedited regulatory review programs in the U.S. and Canada.
“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
“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.”
— Blair Gordon, PhD, Vice President of Research and Development
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