Edesa Biotech Inc.’s first-in-class drug candidate, paridiprubart, has been selected by the Biomedical Advanced Research and Development Authority (BARDA), 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.
 
Paridiprubart represents a new class of HDTs that are designed to modulate the body’s 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.
 
“HDTs have the potential to become key countermeasures for both critical care medicine as well as pandemic preparedness and biodefense, and we are pleased to be part of public-private efforts to speed the development of novel therapeutics that are threat-agnostic and can be rapidly deployed to protect civilian and military populations,” said Par Nijhawan, MD, CEO of Edesa Biotech.

About the Clinical Study

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 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.
 
Dr. Nijhawan explains, “We expect this parallel study to inform our development, regulatory, and commercialization plans. Our ultimate goal is to label paridiprubart as a standard-of-care drug therapy for all-cause ARDS.”
 
The BARDA-funded study will be managed under a BARDA contract with PPD Development, LP, a clinical research business of Thermo Fisher Scientific, Inc. Edesa will provide drug products to the study as well as technical support.