- Company’s host-directed therapeutic, EB05 (paridiprubart), demonstrated a statistically significant mortality reduction among critically ill patients with severe respiratory disease
TORONTO, ON / ACCESSWIRE / September 28, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced the preprint publication of favorable data from a Phase 2 substudy of critically ill patients with a severe form of respiratory disease called Acute Respiratory Distress Syndrome (ARDS). Approximately 10% of all intensive care admissions are ARDS related.
The formal manuscript available today in preprint consists, in part, of mortality rates from critically ill patients who received mechanical ventilation plus additional organ support, including extracorporeal membrane oxygenation (ECMO) therapy, and who were hospitalized for SARS-CoV2-related respiratory disease during the pandemic. Among the findings, a survival analysis using Cox’s Proportional Hazard Model demonstrated that patients treated with EB05 (paridiprubart) plus standard of care had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days. Edesa previously released summarized study results and the preprint manuscript is the first-time that the detailed data is available with supporting tables, listings, figures and references.
Par Nijhawan, MD, Chief Executive Officer of Edesa, said the data demonstrate a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill substudy. “We believe these promising results in one of the most difficult-to-treat populations are encouraging as we explore the therapy’s broader potential utility.”
Paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed to modulate the body’s own immune response when confronted with infectious diseases or even chemical agents. Importantly, these therapies are designed to work across multiple infectious diseases and threats, and could be stockpiled preemptively ahead of outbreaks. Because they are threat agnostic, HDTs like paridiprubart have the potential to become standard of care in ICUs and critical countermeasures for both pandemic preparedness and biodefense.
Based in part on these data, the company initiated a Phase 3 study, and has received a Fast Track designation from the U.S. Food and Drug Administration.
A preprint manuscript, titled “A Phase 2, randomized, double-blind, placebo-controlled multi-center trial sub-study for the clinical effects of paridiprubart treatment in hospitalized critically ill patients with COVID-19 ARDS,” is published on medRxiv at https://www.medrxiv.org/content/10.1101/2023.09.21.23295853v1
