Treatment with BIO 300 to Mitigate COVID-19-Associated Acute Respiratory Distress Syndrome and Related Sequelae
Abstract
The 2019 coronavirus disease (COVID-19) has infected almost 2 million people and caused close to 120,000 deaths in the United States alone. While the National Institutes of Health has put out guidelines on recommended therapies to treat COVID-19, there are no U.S. Food and Drug Administration (FDA)-approved drugs that prevent infection or mitigate its symptoms. One of the most debilitating aspects of COVID-19 is the damage it causes to the lungs. Severe disease typically results in hospitalization and the need for mechanical ventilation or supplemental oxygen. Studies have found that up to 74% of patients hospitalized with COVID-19 develop lung damage. Even worse, up to 45% of patients that are discharged from the hospital still have signs of lung damage as evidenced on CT scans. If this damage is not treated, it may become permanent and dramatically alter the quality of life for patients. Impaired lung function can diminish a person’s ability to perform simple physical tasks and in severe cases make it difficult to breathe at rest. This is particularly problematic for military Service members who may no longer be able to function the same despite recovering from the initial infection. Developing novel drugs to treat lung injury in COVID-19 patients may take several years; however, fortunately, other disease models cause lung damage via a similar mechanism. One of these is radiation-mediated damage to the lungs. Both COVID-19 and radiation trigger an excessive immune response that can damage lung tissue and lead to long-term consequences. Drugs that can mitigate radiation-induced lung damage are good candidates to mitigate lung injury in COVID-19 patients. Humanetics Corporation (Humanetics) is actively developing a radioprotective drug called BIO 300 to mitigate lung injury caused by radiation exposure to the lungs, including cancer patients receiving radiotherapy. BIO 300 is currently being studied in a clinical trial to determine if the drug can prevent lung damage in patients with lung cancer undergoing radiotherapy. A critical outcome from this trial is that no patients have experienced significant side effects related to BIO 300, highlighting the safety of the drug. Furthermore, studies in mice have shown that BIO 300 is able to prevent the harmful effects of radiation exposure to the lungs. BIO 300 is able to mitigate lung injury because it can suppress the harmful inflammatory response caused by the damage, and based on this mechanism, it is an excellent candidate to test in a model of COVID-19. Importantly, under the previous award for which this project is proposing to expand, Humanetics developed a solid dosage formulation of BIO 300 called BIO 300 Oral Powder. One of the major concerns with COVID-19 is the burden it causes to hospitals who may not have enough beds or ventilators to treat all patients. BIO 300 Oral Powder is an oral drug that can be easily self-administered at home, which can lessen the stress on hospitals. In this proposal, we are addressing the PRMRP focus area of respiratory health. Specifically, BIO 300 Oral Powder will be evaluated in a mouse model of COVID-19 as a pharmacological intervention to mitigate COVID-19 pulmonary complications. Since BIO 300 is already in clinical trials, positive results from this research will be the foundation for future human clinical trials in COVID-19 patients. These trials would be the next step in development of BIO 300 for COVID-19. By protecting the lungs from COVID-19, we can mitigate the debilitating consequences of the disease, improve long-term quality of life and reduce the burden placed on hospitals.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110010
Entities
People
- Michael Kaytor
Organizations
- Humanetics Corporation (United States)
- United States Army