Presentations provided an update on a novel solid-dosage formulation of BIO 300


MINNEAPOLIS, MN — Humanetics Corporation (Humanetics) presented data related to its new drug candidate, BIO 300, at the 68th Annual International Radiation Research Society Meeting, held October 16th through the 19th. Michael Kaytor, PhD, Vice President of Research and Development for Humanetics, presented data related to BIO 300 Oral Powder, which is being developed as a medical countermeasure for use by military personnel, first responders, and at-risk civilian populations to prevent radiation damage.  Protection from radiological events is of utmost importance given the current geopolitical climate.

Data presented included the protective effects of BIO 300 Oral Powder for both acute hematological and long-term pulmonary effects of acute radiation exposure when administered prophylactically. BIO 300 Oral Powder efficacy was compared to Neulasta®, an FDA-approved countermeasure that is currently held in the Strategic National Stockpile for use in radiation emergencies. Data were also presented on the recently completed phase 1 clinical study of BIO 300 Oral Powder in healthy volunteers (NCT04650555). This trial evaluated the safety, pharmacokinetics, and biomarkers of single and multiple doses of BIO 300 Oral Powder.

The development of BIO 300 is based upon research initiated by the US Department of Defense, which has granted worldwide exclusive rights to Humanetics for use of the drug as a medical countermeasure for lethal radiation exposure. BIO 300 Oral Powder is a new formulation that was developed to address the unique operational needs of military personnel and first responders. It is a solid oral dosage formulation that is shelf-stable and can be self-administered. This contrasts with current FDA-approved radiation countermeasures that require cold storage and administration through subcutaneous or intramuscular injections.

BIO 300 is also being evaluated in phase 2 clinical trials to prevent normal tissue injury resulting from cancer radiotherapy and to reduce lung damage in COVID-19 long-haul patients. It is administered in these trials as an oral liquid nanosuspension.

The research presented was supported by grants from the US Department of Defense’s Congressionally Directed Medical Research Program. 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.