By Chris Wack
Edesa Biotech Inc. said it saw 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.
The biopharmaceutical company said an independent Data and Safety Monitoring Board informed the company 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.
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 company said. The DSMB further recommended continuation of the study into a Phase 3 confirmatory trial.
Among the findings, the DSMB reported a 28-day death rate of 14.3% in the EB05 arm versus 36.8% in the placebo arm in critically severe patients on extracorporeal membrane oxygenation therapy.
Edesa said the results from the Phase 2 analysis also suggest that EB05 has been generally well-tolerated and consistent with the observed safety profile to date. In addition, 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.
Edesa said it now plans 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. The company intends to file amendments with regulators in the U.S., Canada and Colombia to update the Phase 3 protocol and set targeted enrollment. Edesa said it is also evaluating opportunities to apply for expedited regulatory review programs in the U.S. and Canada.
Edesa shares were up 52% to $8.95 in premarket trading.
Write to Chris Wack at firstname.lastname@example.org
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