Contract Pharma Staff08.20.20
Humanetics Corporation and Pharmaceutics International Inc. are partnering to support a clinical trial of BIO 300 in COVID-19 patients.
The study will focus on patients who were treated for severe COVID-19, discharged from the hospital, and continue to recover at home. These patients face the possible risk that their respiratory complications will continue to progress, leading to long-term impairment similar to the lasting effects of Severe Acute Respiratory Syndrome (SARS).
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 primary endpoint of the trial will be at 12 weeks and patients will be followed for one year.
BIO-300 is a unique, highly selective modulator of inflammation, cell cycle arrest and DNA damage repair being developed for several indications including oncology and defense countermeasures. The patented formulation using suspended nanoparticle technology for improved oral bioavailability, was developed by Humanetics initially for the U.S. Department of Defense to protect military members from harm caused by ionizing radiation. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, awarded funding to conduct the study of BIO 300.
The study will be conducted by physicians at NYU Langone Health with clinical trial material manufactured by Pii, a US-based contract development and manufacturing organization (CDMO). Humanetics and Pii have worked closely together since 2014 on the development of manufacturing techniques for BIO 300 that increase the drug’s oral absorption properties. These improved characteristics allow BIO 300 to be taken by COVID-19 patients in the convenience of their homes. Previous clinical supplies of BIO 300 manufactured by Pii have been used in a clinical trial of non-small lung cancer patients receiving radiation treatments.
There is a growing concern about the long-term health effects caused by COVID-19 infection. Data from survivors show that a significant number have measurable lung damage at discharge from the hospital, which can linger and progress to additional lung abnormalities, including permanent fibrosis. BIO 300 is one of the therapies to be tested in the growing number of survivors who need treatments to mitigate this progressive lung damage.
The study will focus on patients who were treated for severe COVID-19, discharged from the hospital, and continue to recover at home. These patients face the possible risk that their respiratory complications will continue to progress, leading to long-term impairment similar to the lasting effects of Severe Acute Respiratory Syndrome (SARS).
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 primary endpoint of the trial will be at 12 weeks and patients will be followed for one year.
BIO-300 is a unique, highly selective modulator of inflammation, cell cycle arrest and DNA damage repair being developed for several indications including oncology and defense countermeasures. The patented formulation using suspended nanoparticle technology for improved oral bioavailability, was developed by Humanetics initially for the U.S. Department of Defense to protect military members from harm caused by ionizing radiation. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, awarded funding to conduct the study of BIO 300.
The study will be conducted by physicians at NYU Langone Health with clinical trial material manufactured by Pii, a US-based contract development and manufacturing organization (CDMO). Humanetics and Pii have worked closely together since 2014 on the development of manufacturing techniques for BIO 300 that increase the drug’s oral absorption properties. These improved characteristics allow BIO 300 to be taken by COVID-19 patients in the convenience of their homes. Previous clinical supplies of BIO 300 manufactured by Pii have been used in a clinical trial of non-small lung cancer patients receiving radiation treatments.
There is a growing concern about the long-term health effects caused by COVID-19 infection. Data from survivors show that a significant number have measurable lung damage at discharge from the hospital, which can linger and progress to additional lung abnormalities, including permanent fibrosis. BIO 300 is one of the therapies to be tested in the growing number of survivors who need treatments to mitigate this progressive lung damage.
