Edesa Biotech Inc. (NASDAQ: EDSA) stock gained by 4.22% in the current market trading. Edesa Biotech is a clinical-stage biopharmaceutical business dedicated on the development of novel therapies for inflammatory and immune-related illnesses with significant unmet medical needs.
What is happening?
According to EDSA, an independent Data and Safety Monitoring Board (DSMB) performed an interim evaluation of EDSA’s COVID-19 medication candidate and suggested that EDSA’s worldwide trial proceed as planned based on blinded comparison data.
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A pre-planned interim analysis of the first patient cohort in Edesa’s Phase 2/3 clinical study analyzing EDSA’s EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients was conducted by the safety monitoring board, which was made up of independent subject matter experts. The DSMB looked at treatment data to see if it was safe and effective. The DSMB recommended that the trial’s enrolment be continued once they completed their study.
The EDSA has submitted a trial modification with the Food and Drug Administration to simplify the US procedure and bring it in line with those of other countries. Following the exploratory study, EDSA intends to modify its existing patient categorization and objectives, as well as keep blinded data until the completion of Phase 3.
Dr. Par Nijhawan, Chief Executive Officer of Edesa stated,
The DSMB’s recommendation to continue the study is in line with their expectations as well as EB05’s past safety and tolerability profile. While they can’t make any conclusions just yet, the monitoring board’s results, as well as the strong enrolment they’ve seen thus far, give them hope.
Edesa is looking at ways to shorten the time it takes to finish the remaining parts of the study and create a single, strong dataset. The Phase 2/3 research has enrolled over 370 individuals in the United States, Canada, and Colombia as of June 16, 2021. Once therapy is finished and subject data is validated, EDSA expects to conduct the next interim analysis on 316 evaluable individuals.