Full Press Release Details
Edesa Biotech Receives C$14 million for COVID-19 Study
TORONTO, ON / ACCESSWIRE / February 2, 2021 / Edesa Biotech,
Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has
secured a commitment of up to C$14 million (US$ 11 million) from
the Government of Canada to complete the Phase 2 portion of a Phase
2/Phase 3 clinical study of its investigational drug, EB05, for the
treatment of hospitalized COVID-19 patients. The funding will also
help fund certain pre-clinical research intended to broaden the
utility of the company's experimental therapy, including treatments
for other respiratory pathogens. The funds were awarded under the
federal government's Strategic Innovation Fund following a
multi-disciplinary review of Edesa's drug technology and
award of this competitive funding is an important validation of the
therapeutic potential of EB05 and the scientific rationale behind
our efforts. The funds will be targeted toward rapidly getting EB05
into the hands of physicians on the front line of this health
crisis," said Dr. Par Nijhawan, Chief Executive Officer of Edesa.
"By targeting the body's underlying response, our experimental drug
offers a potential solution that could be effective despite
variations in the virus."
Honorable Fran ois-Philippe Champagne, Minister of Innovation,
Science and Industry, said that Strategic Innovation Fund (SIF)
funding announced today is part of the government's plan to support
the development of novel medical countermeasures for COVID-19
patients. "As countries around the world begin to distribute and
administer COVID-19 vaccines to their populations, we cannot lose
sight of the importance of developing treatments to limit the
long-term impacts of the virus on Canadians. Today's contribution
will support Edesa as they take their promising treatment through
clinical trials and subsequent approvals. Once approved, this
therapy has the potential to be an important tool in treating and
preventing lung injuries caused by COVID-19. As the government
continues to protect and support Canadians through this pandemic,
it must also lay the foundation for a better-prepared, healthier
and more prosperous future," he said.
an experimental monoclonal antibody that Edesa believes could
regulate the overactive immune response associated with Acute
Respiratory Distress Syndrome (ARDS) - the leading cause of death
in COVID-19 patients. Specifically, the drug inhibits toll-like
receptor 4 (TLR4) signaling - an important mediator of inflammation
responsible for acute lung injury that has been shown to be
activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal
of the experimental treatment is to suppress inflammation, fluid
accumulation and lung injury, thereby reducing the number of ICU
patients and intubation/ventilation procedures, and ultimately
company intends to use the SIF funding for Phase 2 study expenses.
Edesa's ongoing Phase 2/3 study is an adaptive, multicenter,
randomized, double-blind, placebo-controlled study to evaluate the
efficacy and safety of EB05 in adult hospitalized COVID-19
patients. Up to 316 patients will be enrolled in the first phase of
the trial. Patients will be infused intravenously with a single
dose of EB05 or placebo. Should the antibody treatment demonstrate
promising results at the Phase 2 readout, the company plans to
continue with a pivotal Phase 3 study.
greatly appreciate the support of the Government of Canada and the
effort of the staff of the Innovation, Science and Economic
Development (ISED) department in leading the technical review of
our application," said Michael Brooks, PhD, President of Edesa
Biotech. "We look forward to working with the government on the
next steps in the program and continuing to build on Canada's
emergency preparedness capabilities."
addition to the ongoing clinical study, the SIF funding will also
be used to support a research project at a Canadian university.
Among other objectives, the in
vitro pre-clinical study will examine the potential
therapeutic utility of EB05 against a panel of pathogens, including
coronavirus variants and influenza strains.
and physicians interested in participating in the Phase 2/3 study
of EB05 should contact info@edesabiotech.com
or visit www.clinicaltrials.gov
(Identifier: NCT04401475)
Respiratory Distress Syndrome is the leading cause of death in
COVID-19 patients. The U.S. Centers for Disease Control (CDC)
reports that 20% to 42% of hospitalized COVID-19 patients develop
ARDS, which increases to 67% to 85% for patients admitted to the
ICU. Mortality among patients admitted to the ICU ranges from 39%
to 72% depending on the study and characteristics of patient
population, according to the CDC. ARDS involves an exaggerated
immune response leading to inflammation and injury to the lungs
that results in edema that deprives the body of oxygen. For
moderate to severe cases, there are currently few meaningful
treatments, other than supplemental oxygen and mechanical
ventilation, and patients suffer high mortality rates. In addition
to virus-induced pneumonia, ARDS can be caused by smoke/chemical
inhalation, sepsis, chest injury and other causes. Prior to
COVID-19, ARDS accounted for approximately 10% of intensive care
unit admissions, representing more than 3 million patients globally
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage
biopharmaceutical company focused on developing innovative
treatments for inflammatory and immune-related diseases with clear
unmet medical needs. Edesa's lead product candidate, EB01, is a
novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor)
for the treatment of chronic allergic contact dermatitis which has
demonstrated statistically significant improvements in multiple
clinical studies. The company is developing late-stage monoclonal
antibodies that block certain immune signaling proteins, known as
TLR4 and CXCL10. These molecules are associated with a broad range
of diseases, including the inflammation associated infectious
diseases. Due to the global health emergency, Edesa has prioritized