Benzinga | Jan 11, 2021 07:33AM EST

Edesa Biotech Expands COVID-19 Clinical Study To Colombia

TORONTO, ON / ACCESSWIRE / January 11, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from the Ministry of Health (INVIMA) in Colombia to expand the clinical trial of its investigational drug EB05 in hospitalized COVID-19 patients. The study was previously approved in the U.S. and Canada, where enrollment is ongoing. The company reported that it has enlisted the support of a local research organization and will begin activating hospital sites in Bogota, Medell?n, Bucaramanga, and other major metropolitan centers.

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.

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, the company believes that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said the investigative sites in Colombia are among the best in Latin America, with well-established programs adhering to Good Clinical Practices and other internationally accepted standards, and the company looks forward to joining other pharmaceutical companies in extending innovative treatments to nations in Latin America.

"We greatly appreciate the actions being taken by the Colombian government to review and approve our clinical study. Collaborating with physicians and hospitals in Colombia allows us to complete this important study more quickly and reaffirms our commitment to provide broad access to a promising experimental treatment to people around the world," 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.

Edesa's international 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. Edesa plans to enroll approximately 316 patients in the Phase 2 portion of the study. Data from the Colombian, Canadian and U.S. sites will be aggregated and analyzed together. Should the drug treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a Phase 3 study.

Hospitals interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).