Trial finds BIO 300 Oral Powder to be safe in 34 healthy volunteers


MINNEAPOLIS, MN — Humanetics Corporation (Humanetics) announced the publication of results from their recently completed phase 1 trial of BIO 300 Oral Powder in healthy volunteers in the journal Clinical Pharmacology in Drug Development (NCT04650555). BIO 300 Oral Powder is the Company’s medical countermeasure under development to prevent acute radiation syndrome (ARS). The article details results from the trial including safety, pharmacokinetics, and biomarkers in 34 healthy volunteers. No dose-limiting or dose-dependent toxicities were reported, and BIO 300 Oral Powder was found to be safe and well-tolerated. Biomarkers identified in this study were supportive of the radioprotective mechanism of BIO 300 Oral Powder. The trial was funded by the US Department of Defense’s Joint Warfighter Medical Research Program and conducted at Nucleus Network, LLC (St. Paul, MN).

Members of the military and first responders may have to operate in areas of known or potential risk of radiation exposure. Persons exposed to radiation may develop ARS, which consists of numerous serious and life-threatening injuries and there are currently no FDA-approved drugs that prevent ARS and can be administered prior to radiation exposure. BIO 300 Oral Powder is a new solid dosage formulation that is shelf stable and designed for self-administration in the field by military personnel and first responders. BIO 300 is based on research conducted by the US Department of Defense, which has granted worldwide exclusive rights to Humanetics for BIO 300’s use against lethal radiation exposure. BIO 300 was recently granted Fast Track designation by the U.S. Food and Drug Administration for the prevention of ARS.

BIO 300 is also in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics recently completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799).  In addition, a phase 2b trial is currently in progress evaluating the use of BIO 300 to protect lung tissues in COVID-19 long haulers (NCT04482595).

The views expressed herein are those of Humanetics Corporation and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the US Government.