Edesa Biotech Sees Positive Results From Study for Covid-19 Treatment
September 20 2021 - 9:00AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
September 20, 2021 08:45 ET (12:45 GMT)
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