BIO 300 will be given to patients to evaluate its potential to prevent progressive lung injury
Minneapolis, MN – Humanetics Corporation (Humanetics) announced today that it has received funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to conduct a study of its drug, BIO 300, in COVID-19 patients. The study will focus on patients who were treated for severe COVID-19 disease, many of whom were discharged from the hospital and are recuperating at home. These patients face the possible risk that their respiratory complications will continue to progress, leading to long-term impairment of lung function.
Although much is to be learned about the long-term effects of COVID-19, data from the 2003 outbreak of a related coronavirus disease, known as Severe Acute Respiratory Syndrome (SARS), provides a glimpse of the possible long-term effects for recovering patients. The SARS epidemic affected a much smaller number of people worldwide; however, two studies of SARS patients showed that 30-45% of patients developed pulmonary fibrosis within 12 months. Early studies with COVID-19 patients also indicate that a high number of infected individuals exhibit signs of injury within the first few weeks of infection, and that as many as 50% of patients have signs of pulmonary fibrosis and/or impaired lung function at the time of hospital discharge. Pulmonary fibrosis results in permanent scarring of the lungs, which can impair breathing and greatly impact a person’s quality of life.
BIO 300 is an oral drug that patients will self-administer daily for 12 weeks following discharge from the hospital. The primary endpoint of the trial will be at 12 weeks and patients will be followed for one year. The study will compare the lung function, exercise capacity and quality of life in COVID-19 survivors who receive BIO 300, against a group receiving a placebo.
The study will be conducted by physicians at NYU Langone Health, which has treated over 10,000 COVID-19 patients. Rany Condos, MD, who is leading efforts at NYU Langone to set up a post COVID-19 recovery clinic and patient registry, will lead the BIO 300 study. NYU Langone plans to follow patients long-term to better understand the effects of recovering from COVID-19.
“We don’t fully understand the long-term effects of COVID-19 and are concerned that discharged patients will continue to suffer respiratory complications,” said Daniel Sterman, MD, Director of the Division of Pulmonary, Critical Care & Sleep Medicine at NYU Grossman School of Medicine. “This placebo-controlled double-blind study is an attempt to understand if 12 weeks of BIO 300 can mitigate lasting COVID-19 effects in the lungs and improve the quality of life for patients. We
will continue to track them for one year to gain a better understanding of the lasting effects of the drug on COVID-19 injury.”
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 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 National Institute of Allergy and Infectious Diseases, a component of the NIH, Department of Health and Human Services, under Contract HHSN272201800011C.
Humanetics is a clinical-stage pharmaceutical company engaged in the discovery, development and commercialization of proprietary drugs to prevent severe tissue damage caused by exposure to radiation, viral infection and other inflammatory diseases. For more information, visit humaneticscorp.com.
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 350+ locations throughout the New York area are six inpatient locations: Tisch Hospital, its flagship acute-care facility; Kimmel Pavilion, its state-of-the-art healthcare facility, opened in 2018; NYU LangoneOrthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children’s Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children’s health services; NYULangone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn; and NYU Winthrop Hospital, a 591-bed hospital and level 1 trauma center located in Mineola, Long Island. Also part of NYU Langone Health is the Laura and IsaacPerlmutter Cancer Center, a National Cancer Institute–designated comprehensive cancer center, and NYU Grossman School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. For more information, go to nyulangone.org, and interact with us on Facebook,