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FDA Grants Fast Track to Edesa Biotech's ARDS Drug Candidate
2022-12-20 08:31 ET - News Release
- Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients.
TORONTO, ON / ACCESSWIRE / December 20, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05. Approval of the company's application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs.
The Fast Track program provides Edesa with the opportunity for more frequent communication with the agency to discuss the development path for EB05 as a treatment for ARDS in critically ill Covid-19 patients. Investigational drugs that receive Fast Track designation are also eligible for rolling review of their marketing application as well as potential pathways for accelerated regulatory approval. To receive this designation, drug candidates must both treat a serious disease and have non-clinical or clinical data that demonstrate the potential to address an unmet medical need.
Par Nijhawan, MD, Chief Executive Officer of Edesa, said that FDA's decision is a significant development milestone for the company. "Fast Track designation provides additional validation of EB05's potential to address a significant unmet need in hospitalized patients with ARDS," said Dr. Nijhawan. "The Fast Track designation will facilitate our interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program."
Edesa recently reported that Phase 2 results offered statistically significant evidence of EB05's ability to reduce death in the most critically ill hospitalized Covid-19 patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.
About EB05
EB05 is a monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses.
About Acute Respiratory Distress Syndrome (ARDS)
ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.
About Edesa Biotech, Inc.