Humanetics Corporation (Humanetics) announced that it has received funding from the U.S. Department of Defense to conduct a series of studies with its new drug candidate, BIO 300. BIO 300 is believed to prevent and mitigate acute and chronic inflammatory diseases and radiation toxicities. The studies will focus on the ability of BIO 300 to mitigate progressive pulmonary inflammation caused by COVID-19, which leads to acute respiratory distress. If adopted, the drug may prevent hospitalizations and mitigate progressive and long-term pulmonary effects that are becoming increasingly evident in COVID-19 patients.
The studies will be conducted by researchers at Battelle in Columbus, Ohio. Battelle is a leader in research and development of medical countermeasures with significant experience and capabilities related to the study of infectious diseases. It is one of only a few high-containment facilities in the nation capable of working with highly infectious agents such as the SARS-CoV-2 virus (the virus that causes COVID-19).
BIO 300 is currently the subject of a phase 2 RDBPC clinical trial in patients who have been hospitalized with acute respiratory disease syndrome caused by COVID-19. This trial is being funded by the National Institute of Allergy and Infectious Diseases (NIAID) and is being conducted by clinicians at NYU’s health system in New York. In this study, patients are self-administering BIO 300 at home for 12 weeks following discharge from the hospital. This new funding will evaluate the use of BIO 300 before or shortly after SARS-CoV-2 infection in an effort to quell the progressive effects of COVID-19 and prevent serious complications and illness.
“We intend to demonstrate that the drug can be used both prophylactically to prevent initial COVID-19 complications and as a therapeutic to mitigate lingering symptoms after hospitalization,” said Ronald Zenk, President and CEO of Humanetics. “In addition to civilian treatment, there is also military relevance for our drug to support warfighter operational readiness and reduce lost duty time.”
BIO 300 is under advanced development by Humanetics as a medical countermeasure to protect the body from harm caused by ionizing radiation. It was initially discovered by researchers at the U.S. Department of Defense in their efforts to create radio-protective drugs for the military. Humanetics further expanded applications for the drug into cancer radiation therapy and recently completed a clinical trial in lung cancer patients who develop pulmonary injury related to their radiation treatments. Radiation-induced injury to normal lung tissue in cancer patients is similar to lung injury caused by COVID-19. BIO 300 has been shown to mitigate inflammation of the lungs (pneumonitis) and pulmonary fibrosis caused by radiation. It is believed that the same effect can be shown in COVID-19 patients.
This project has been funded by the U.S. Department of Defense under its Congressionally Directed Medical Research Program. The views expressed in this article are those of the author and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.