BIO 300 will be tested as a treatment to mitigate lung scarring in idiopathic pulmonary fibrosis

Humanetics Corporation (Humanetics) announced today that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. The funding will support a series of studies with its new drug candidate, BIO 300. BIO 300 is believed to prevent and mitigate acute and chronic inflammatory pulmonary diseases, including radiation toxicities. The studies will focus on the ability of BIO 300 to attenuate progressive pulmonary fibrosis as a potential treatment for idiopathic pulmonary fibrosis (IPF). IPF is a progressive and ultimately fatal lung disease that affects approximately 3 million people worldwide. IPF is associated with a particularly poor prognosis, with most patients succumbing to the disease within 3-5 years from diagnosis.

Therapeutics have been approved by the FDA for the treatment of IPF based on their ability to slow the rate of lung function decline. Unfortunately, these treatments have not been shown to significantly alleviate IPF symptoms or improve patient quality of life. This SBIR project aims to evaluate the utility of BIO 300 as a treatment for IPF by measuring its ability to reduce pulmonary fibrosis in an accepted preclinical model of IPF. The studies supported by this SBIR grant will provide the foundation for future work to support the translation of BIO 300 toward a clinical treatment for patients with IPF. If adopted, BIO 300 has the potential to transform the current treatment paradigm for IPF.

U.S. Department of Defense researchers initially discovered BIO 300 in their efforts to develop radioprotective drugs for the military. BIO 300 is under advanced development by Humanetics as a medical countermeasure to protect the body from harm caused by ionizing radiation. Notably, the drug has been shown to mitigate inflammation of the lungs (pneumonitis) and pulmonary fibrosis caused by radiation. Humanetics further expanded applications for the drug into cancer radiation therapy, COVID-19, and other inflammatory pulmonary diseases. Results from a completed trial of BIO 300 in patients with lung cancer receiving radiotherapy were recently published (Simone et al., 2023). BIO 300 is also the subject of an ongoing phase 2 clinical trial in patients hospitalized with acute respiratory disease syndrome caused by COVID-19 (NCT04482595). We believe BIO 300’s therapeutic effects on radiation-induced injury to normal lung tissue and its therapeutic potential to lessen long-term pulmonary injury in patients with COVID-19 will translate to a clinical benefit in patients with IPF.

“We intend to demonstrate that the drug can be used to reduce devastating lung scarring in patients with IPF,” said Mr. Ronald Zenk, President and CEO of Humanetics. “In doing so, BIO 300 has the potential to significantly improve quality of life for these patients.”

About Humanetics Corporation

Humanetics is a clinical-stage pharmaceutical company engaged in discovering, developing, and commercializing proprietary drugs to prevent severe tissue damage caused by exposure to radiation, viral infection, and other inflammatory diseases. For more information, visit humaneticscorp.com.

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