Edesa Biotech's Drug Chosen for U.S.-Funded ARDS Trial by BARDA

Edesa Biotech, Inc., a clinical-stage biopharmaceutical company listed on Nasdaq (EDSA), has announced that its innovative drug candidate, paridiprubart (EB05), has been selected for evaluation in a U.S. government-funded clinical study. This selection was made by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, following a competitive assessment of various therapeutic candidates.

Paridiprubart represents a new class of host-directed therapeutics (HDTs) designed to modulate the immune system's response to various threats including pandemic influenza, COVID-19, and other infectious diseases, as well as chemical, biological, radiological, and nuclear incidents. Unlike traditional treatments that target specific pathogens, HDTs are agnostic to the causal agent, allowing for preemptive stockpiling to address public health emergencies and biodefense needs.

Edesa's CEO, Dr. Par Nijhawan, emphasized the potential of HDTs in critical care and pandemic preparedness, noting the importance of public-private collaborations to accelerate the development of novel, threat-agnostic therapeutics for civilian and military populations.

The BARDA-funded Phase 2 clinical trial will be a randomized, double-blinded, placebo-controlled, multi-center study in the U.S. It aims to investigate three novel HDTs, including paridiprubart, in hospitalized adults with Acute Respiratory Distress Syndrome (ARDS). The study builds on the success of an earlier Phase 2 trial conducted during the COVID-19 pandemic, which demonstrated an 84% reduction in mortality among critically ill ARDS patients treated with paridiprubart. An in vitro model study also showed that paridiprubart could inhibit a key inflammatory response mediator from influenza and other pathogens. Concurrently, Edesa is conducting a Phase 3 study of paridiprubart in ARDS patients with SARS-CoV-2 infections in Canada and the U.S.

Dr. Nijhawan highlighted that the BARDA-run study, which includes an exploratory biomarker component, could provide valuable insights and support for the further development, regulatory approval, and commercialization of paridiprubart. The ultimate goal is to establish paridiprubart as a standard-of-care therapy for all-cause ARDS.

The study will be managed under a BARDA contract with PPD Development, LP, a division of Thermo Fisher Scientific, Inc. Patients enrolled in the paridiprubart cohort will be randomized to receive either paridiprubart plus Standard of Care (SOC) or a placebo plus SOC. Edesa will supply the drug products and provide technical support. Further details about the trial are available on the BARDA website.

ARDS, a severe condition characterized by an exaggerated immune response leading to lung inflammation and injury, has few effective treatments beyond supplemental oxygen and mechanical ventilation. ARDS can result from various causes such as virus-induced pneumonia, smoke or chemical inhalation, sepsis, and chest injury, and has high mortality rates. Before the pandemic, ARDS was responsible for 10% of intensive care unit admissions worldwide, affecting over 3 million patients annually.

Paridiprubart is a first-in-class human monoclonal antibody designed for both acute and chronic conditions involving dysregulated immune responses. It inhibits toll-like receptor 4 (TLR4), a crucial immune signaling receptor activated by viruses and in chronic autoimmune diseases.

Edesa's ongoing Phase 3 study of paridiprubart is a multicenter, randomized, double-blind, placebo-controlled trial evaluating its efficacy and safety in ARDS patients hospitalized with SARS-CoV-2 infections and on invasive mechanical ventilation. The primary endpoint is the mortality rate at 28 days.

Edesa Biotech, Inc. is committed to developing innovative treatments for inflammatory and immune-related diseases. Besides paridiprubart, the company is advancing EB01, a topical treatment for chronic allergic contact dermatitis, and preparing for a Phase 2 trial of EB06 for vitiligo. Additionally, Edesa plans to submit an investigational new drug application for a Phase 2 study of paridiprubart for pulmonary fibrosis.