Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company that focuses on inflammatory and immune-related diseases, has announced that after successful negotiations with the U.S. Food and Drug Administration (FDA), they have agreed on the primary endpoint and population for a pivotal Phase 3 study involving their monoclonal antibody candidate, EB05, as a potential therapy for hospitalized patients with severe respiratory failure. In addition, the FDA has granted the program Fast Track designation, indicating their confidence in the potential of this therapy.
Today, Edesa announced a significant agreement following the highly promising results from their Phase 2 trial of their investigational drug, EB05. This medicine has shown the remarkable potential to reduce mortality rates in those suffering from the most severe symptoms of Acute Respiratory Distress Syndrome (ARDS). In the trial, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an impressive 84% reduction in the risk of dying when compared to those given placebo plus standard of care at 28 days. This agreement marks a major milestone in the fight against ARDS and its devastating effects.
Edesa has revised their protocol to evaluate the efficacy of their treatment on a single cohort of severely ill patients on invasive mechanical ventilation. With the aim of enrolling approximately 600 evaluable hospitalized subjects, Edesa will compare the mortality rate at 28 days, ventilator-free days at 28 days, and mortality at 60 days between patients with and without additional organ support such as extracorporeal membrane oxygenation (ECMO). This innovative study could prove to be a pivotal moment in determining the best possible treatment for these critically ill patients.
Edesa is delighted to announce a major milestone in the development of its lead product candidate, following successful discussions with the FDA. The FDA has proposed a 28-day mortality endpoint for the Phase 3 study, which was the company’s preferred efficacy endpoint. This is a major step forward in providing effective treatment options for severely ill patients and brings the study closer to completion.
Dr. Nijhawan has announced the approval of the amended U.S. protocol by the study’s independent ethics committee, the Institutional Review Board (IRB). The company has now started recruitment at U.S. hospital sites and will continue to expand in the coming quarters as these sites complete their training on the new protocol.
Dr. Nijhawan has designed an efficient, streamlined protocol to make it easier to recruit participants and conduct a study on general Acute Respiratory Distress Syndrome (ARDS). This updated protocol is no longer tied to the World Health Organization Covid-19 Severity Scale, making it a useful tool for researchers to gain further insights into ARDS.
EB05, an investigational therapy designed to target the patient’s own immune response, could have broad applications across multiple disease indications, such as ARDS caused by influenza and other deadly pathogens. By targeting the patient’s own immune response, EB05 is independent of the infectious agent and could potentially help treat a variety of diseases. The company is currently exploring approaches to evaluate EB05 in a general ARDS population.
Medimmune’s monoclonal antibody MEDI8852 (EB05) has been designed to target a key component of the body’s immune system: toll-like receptor 4 (TLR4). By blocking TLR4 signaling, MEDI8852 has been shown to reduce the activity of SARS-CoV-2, SARS-CoV-1 and Influenza viruses, offering a potential new approach to tackling these diseases.
About Acute Respiratory Distress Syndrome (ARDS)
ARDS is a devastating condition that affects millions of people globally each year, causing an exaggerated immune response leading to inflammation and injury of the lungs that prevent them from oxygenating the blood. This deprives the body of oxygen, resulting in a high mortality rate for those with moderate to severe cases, who are typically treated only with supplemental oxygen and mechanical ventilation. Although most cases of ARDS are virus-induced pneumonia, it can also be caused by smoke/chemical inhalation, sepsis, chest injury, and other sources. Pre-Covid-19, ARDS was responsible for 10% of intensive care unit admissions.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is on the cutting edge of innovative treatments for inflammatory and immune-related diseases. Their most advanced drug candidate, EB05, is a monoclonal antibody being studied in a Phase 3 clinical trial as a potential treatment for Acute Respiratory Distress Syndrome (ARDS). Edesa is also developing EB01, an sPLA2 inhibitor, as a topical treatment for chronic Allergic Contact Dermatitis (ACD). Additionally, the company has received regulatory approval for a Phase 2 trial of its EB06 monoclonal antibody for vitiligo, a life-altering autoimmune disease. With Edesa’s exciting pipeline of potential treatments, they are poised to make a major impact on the future of medicine. Stay up to date with the latest developments by signing up for news alerts.