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etra's ARDS-003 receives FDA nod for clinical dev
2021-04-05 06:06 ET - News Release
Dr. Guy Chamberland reports
FDA PROVIDES POSITIVE FEEDBACK ON TETRA BIO-PHARMA'S APPLICATION FOR ARDS-003 CLINICAL DEVELOPMENT IN COVID-19 PATIENTS
The U.S. Food and Drug Administration (FDA) has favourably reviewed the preclinical data package and clinical development plan of Tetra Bio-Pharma Inc.'s ARDS-003 to treat COVID-19 patients.
The review was conducted within the framework of the coronavirus treatment acceleration program (CTAP), the FDA's expedited process for investigational therapies to treat COVID-19 patients. Over all, the FDA agreed with the animal toxicology and safety data to ensure that ARDS-003 is safe for human use, and approved the sample size, safety procedures and duration of treatment in severe COVID-19 patients. As a result of this feedback, the company looks forward to filing an investigational new drug application to initiate the clinical trial.
The proposed patient study is a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome.
Seeking guidance on clinical study protocol to be conducted in patients with COVID-19 is a prerequisite of the FDA regulatory process for COVID-19-related trials, as it is for Health Canada.
Dr. Guy Chamberland, chief executive officer and chief research officer, commented: "I'm very pleased with the FDA feedback on our data package and clinical strategy. Such feedback gives us a great insight on the authority's positive perception of our product and will facilitate the IND review process. I'm confident that we are now aligned with the authorities for the development plan of ARDS-003."
ARDS-003 is a new patent-protected therapeutic developed to treat hyperinflammatory conditions, such as those seen in patients suffering from COVID-19 viral infections. The investigational drug is designed to dampen the cytokine release syndrome and will be administered in combination with dexamethasone. The company is not making any express or implied claims that its product has the ability to eliminate, cure and/or contain the COVID-19 virus at this time.
Severe COVID-19-induced hyperinflammatory syndrome
ARDS is the leading cause of mortality in COVID-19 patients and develops in 20 to 67 per cent of critically ill patients diagnosed with COVID-19 and 76 per cent of patients requiring ICU (intensive care unit) care. Studies report that of those COVID-19 patients who are critically ill, profound acute hypoxemic respiratory failure secondary to ARDS represents the leading finding, and that 30 to 100 per cent of these patients require mechanical ventilation. Further, additional organ systems including the cardiovascular system are profoundly impacted by the hyperinflammation in COVID-19 patients. Presently, no standard, approved treatment for hyperinflammation and associated ARDS or multiorgan dysfunction syndrome (MODS, a common cause of death) exists for these patients, rendering the indication a significant unmet medical need. Targeting hyperinflammation via immunosuppressive or anti-inflammatory agents is likely to be beneficial in COVID-19-associated CRS. The use of low-dose dexamethasone is part of standard of care for COVID-19 and has been correlated with decreased COVID-19 mortality and reduction in need for mechanical ventilation. Given that the anti-inflammatory effect of ARDS-003 is broader than the anti-inflammatory effect of dexamethasone and presents a safer safety profile, it is believed that the addition of ARDS-003 to dexamethasone standard of care treatment will result in additional benefit for the patients.