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 plans.
“The 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.”
The Honorable François-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.
EB05 is 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 saving lives.
The 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.
“We 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.”
In 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.