BARDA selects Edesa Biotech drug for U.S. funded platform trial in ARDS

Edesa Biotech announced that its first-in-class drug candidate has been selected by the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for evaluation in a U.S. government-funded clinical study. Edesa’s drug paridiprubart represents a new class of HDTs that are designed to modulate the body’s own immune response when confronted with known or unknown public health threats such as pandemic influenza, COVID-19, other emerging infectious diseases, and chemical, biological, radiological, and nuclear incidents. Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense. The BARDA-funded Phase 2 platform trial will be a randomized, double-blinded, placebo-controlled, multi-center U.S. clinical trial to investigate three novel threat-agnostic host-directed therapeutics, including paridiprubart, in hospitalized adult patients with ARDS. The BARDA study of paridiprubart is expected to build on the success of a Phase 2 clinical study that the company completed during the COVID-19 pandemic which demonstrated that paridiprubart reduced mortality by 84% among critically ill ARDS patients. A parallel study using an in vitro model also demonstrated that paridiprubart inhibits a key mediator of inflammatory responses from influenza and other pathogens. A separate Edesa-sponsored Phase 3 study of paridiprubart in patients with ARDS due to SARS-CoV-2 infection is currently ongoing in Canada and the U.S. The BARDA-funded study will be managed under a BARDA contract with PPD Development, LP, a clinical research business of Thermo Fisher Scientific, Inc. For the paridiprubart cohort of the study, patients will be randomized one-to-one to either paridiprubart plus Standard of Care or to a placebo plus SOC control arm. Edesa will provide drug products to the study as well as technical support