Inflammatory Lung Diseases
Humanetics is developing BIO 300 as a treatment to prevent and mitigate the effects of inflammatory lung diseases. A focus of this effort is the prevention of lung injury causes by corona viruses, including COVID-19, which can have long lasting effects on the lungs. In the similar disease, SARS, pulmonary fibrosis due to ARDS is considered the primary reason patients that recovered have a lower quality of life. Two studies of patients with SARS showed that 45% of patients and 28% of patients had radiographic signs of pulmonary fibrosis within 12 months after infection. Studies of COVID-19 have found that 50-75% of patients have residual lung damage at the time of discharge (e.g., ground glass opacity) These findings highlight the progressive nature of lung injury associated with this disease. There are currently no FDA approved therapeutics to mitigate the pulmonary complications associated with COVID-19.
BIO 300 Protects the Lungs from Harmful Inflammation
BIO 300 represses expression and activation of NF-kB, a master regulator of the inflammatory response in cells. NF-kb is activated in the lungs after radiation exposure or viral infection. Once activated, NF-kB promotes expression of several pro-inflammatory cytokines, such as interleukin 1 (IL-1), IL-6 and IL-8. Overproduction of these cytokines triggers a severe immune reaction called a cytokine storm which can damage lung tissue and result in permanent scarring called fibrosis. By impeding NF-kB, BIO 300 is able to mitigate this severe immune response, lower levels of pro-inflammatory cytokines and protect the lung tissue. Through this mechanism, BIO 300 can protect the lungs from the delayed effects of acute radiation exposure or respiratory viral diseases such as COVID-19.
Clinical Study in COVID-19 Patients - Phase 2 (Recruiting)
BIO 300 Phase 2 Study in Discharged COVID-19 Patients The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension to mitigate long term lung injury in COVID-19 patients discharged from the hospital.
- NYU Langone Health - New York, NY
- University of Colorado Anschutz Medical Campus - Aurora, CO
- Houston Methodist Research Institute, Houston, TX
More details are available at ClinicalTrials.gov
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor should visit the study site on ClinicalTrials.gov.