MINNEAPOLIS--(BUSINESS WIRE)--Humanetics Corporation (Humanetics) is pleased to announce the positive results from the independent Data Safety Monitoring Board (DSMB) review of its phase 2 clinical trial of BIO 300 in patients with COVID-19. The DSMB conducted an interim analysis of the unblinded trial data and determined that the study is not futile, and that it is reasonable to continue with the trial.
The positive results from the DSMB suggest that the trial is progressing as expected with respect to patient safety and efficacy and has an opportunity to meet its primary endpoint. The phase 2 clinical trial is evaluating the safety and efficacy of BIO 300, a novel treatment designed to prevent long-term lung complications in COVID-19 patients. The trial is being conducted at clinical sites in New York and Houston (NCT04482595).
"We are extremely pleased with the positive results from the DSMB review, as they provide support to continue with this important clinical trial," said Ronald J. Zenk, CEO of Humanetics. "We are grateful for the opportunity to continue advancing the development of BIO 300 and are committed to collaborating with our clinical partners as we move this important drug forward."
BIO 300 is also in development as a medical countermeasure for use by the United States Department of Defense and for oncology applications to protect patients from side effects caused by radiation. Humanetics recently completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799).
This project is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201800011C.
About Humanetics Corporation
Humanetics is a clinical-stage specialty pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures to prevent harm caused by exposure to radiation, for protective use in cancer radiation therapy, and to guard against the long-term damaging effects of COVID-19. For more information, visit humaneticscorp.com.
