- Edesa Biotech (NASDAQ:EDSA) jumps 10% premarket following a report that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the company's COVID-19 drug candidate, and has recommended the study to continue as planned.
- An interim review of the first patient cohort participating in Edesa's Phase 2/3 study evaluating EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients was conducted.
- The DSMB assessed treatment data for safety and futility, and after completing their analysis, recommended that enrollment in the trial to continue.
- Dr. Par Nijhawan, CEO, said that Edesa is evaluating opportunities to expedite the timeline for completing the remaining part of the study. As of June 16, 2021, more than 370 subjects in the U.S., Canada and Colombia have been enrolled.
- The company plans to perform the next interim analysis on 316 evaluable subjects once treatment is completed and subject data is validated and aggregated.