Edesa Biotech Filed an IND for EB05
Edesa Biotech (EDSA), a clinical-stage biopharmaceutical company, has filed an investigational new drug (IND) application with the U.S. FDA for the initiation of a Phase 2/3 clinical study of its investigational drug EB05. Edesa has recently received expedited approval to begin the Phase 2/3 study in Canada and is seeking government grants to accelerate site selection and initiate patient enrollment.
Edesa Biotech Investigational Drug EB05
EB05 experimental product is a monoclonal antibody that Edesa Biotech believes could regulate the overactive immune response of the Acute Respiratory Distress Syndrome (ARDS) which is considered a leading cause of death in COVID-19 patients. The IND application is filed with the U.S. FDA for the treatment of hospitalized COVID-19 patients.
Mode of action: EB05 inhibits toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury. It has been shown to be activated by SARS-CoV1 and Influenza viruses.
The previous clinical data and the mechanism of action have convinced Edesa Biotech that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.
EB05 safety and tolerability has been demonstrated in more than 120 subjects. The antibody therapy has demonstrated an ability to resolve fever as well as stabilized heart rates and breathing rates in test subjects who were injected with a potent inducer of acute systemic inflammation.
Dr. Par Nijhawan, Chief Executive Officer of Edesa, said, “The submission of the IND for EB05 in COVID-19 patients marks a key step in our plans to extend our planned Phase 2/3 study. We received positive interest from key opinion leaders regarding our proposed clinical trial and are communicating with hospitals across the country regarding our protocol.”
Edesa Biotech Phase 2/3 Study
Edesa’s Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study that evaluates the efficacy and safety of EB05 in adult hospitalized patients who have or are at risk of developing ARDS. Edesa said that its plan is to enroll up to 450 patients in the first phase of the trial. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the treatment demonstrate promising results at the Phase 2 readout, the protocol allows for enrollment to continue as a pivotal Phase 3 study.
Acute Respiratory Distress Syndrome (ARDS)
The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS which increases to 67% to 85% for patients admitted to the ICU. According to the CDC mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of the patient population.
ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that results in edema that deprives the body of oxygen. A few meaningful treatments exist for moderate to severe cases other than supplemental oxygen and mechanical ventilation.
In addition to virus-induced pneumonia ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury as well as other causes. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually.
Edesa Biotech is a clinical-stage biopharmaceutical company focusing on developing treatments for inflammatory and immune-related diseases. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) being developed for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies.
The company is also developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including inflammation associated infectious diseases. Due to the global health emergency Edesa has prioritized the development of EB05 as a potential treatment for moderate to severe COVID-19 patients.
The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California.
Countering Hyper-Immune Responses the firm’s novel monoclonal antibodies suppressing TLR4 and CXCL10, known to be associated with a broad range of diseases, including the inflammation associated with infectious diseases like COVID-19.
Filing IND for the initiation of a Phase 2/Phase 3 clinical study of its investigational drug EB05 boosted the firm’s stock price. The stock is currently experiencing volatility, jumping from less than $11 to over $12 and vise versa with an average gain of a little more, or a little less than 100%.
We decided not to put a target for Edesa’s stock until we see how the stock price volatility will end up after trading hours today. We also believe that our evaluation of the firm will be more accurate after we compare the results of the firm’s product trial results on chronic allergic contact dermatitis with other firms’ recently approved products for the same skin disease.
We will post an article about Compugen under Impacting News.
To read more about our COVID-19 coverage please click here.