Benzinga | Nov 30, 2020 07:32AM EST

Edesa Biotech Enrolls First Patient in COVID-19 Study

Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2/Phase3 clinical trial evaluating the company's investigational drug, EB05, as a therapy for hospitalized COVID-19 patients.

EB05 is a clinical-stage monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The drug is delivered intravenously in a single infusion to hospitalized COVID-19 patients.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that EB05 is intended to fill a critical gap in combatting the pandemic - alongside anti-viral treatments and vaccines under development by others. Based on previous clinical data and the mechanism of action, Dr. Nijhawan believes that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.

"Initiating this study brings us one step closer to providing effective treatment options for patients facing some of the worst effects of the SARS-CoV2 infection. By preventing or treating ARDS, our drug candidate could help lessen concerns about COVID-19 by providing a treatment option even for the most serious patients," said Dr. Nijhawan.

Edesa's drug works by directly inhibiting a pattern recognition receptor called toll-like receptor 4 (TLR4), which has been shown to mediate inflammation as a result of infection by SARS-CoV2 and other respiratory infections such as influenza. Recent third-party studies have demonstrated that severe COVID-19 patients frequently display elevated levels of certain damage-associated molecule patterns (DAMPs) that activate TLR4. Edesa believes targeting this key innate signaling pathway with EB05 could potentially disrupt the overactive and self-amplifying network of downstream proinflammatory cytokines, and thereby, reduce morbidity and mortality in hospitalized COVID-19 patients. The antibody therapy has previously demonstrated an ability to resolve fever as well as stabilize heart rates and breathing rates in test subjects who were injected with a potent inducer of acute systemic inflammation. The safety and tolerability of EB05 has been demonstrated in more than 120 subjects.

Blair Gordon, PhD, Vice President of Research and Development of Edesa, said that Edesa plans to enroll approximately 316 patients in the Phase 2 portion of the multicenter, double-blind, placebo-controlled study. The company expects to enroll up to approximately 40 hospitals in the study.

"We are excited to announce the first patient was dosed in Toronto, Ontario and we look forward to providing access to this promising therapy to patients across both Canada and the U.S.," said Dr. Gordon. "Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study."