Presentation to update the advanced development of BIO 300, an orally available medical countermeasure for Warfighters, to prevent toxicities due to radiation exposure.
MINNEAPOLIS--(BUSINESS WIRE)--Updates on the development of Humanetics Corporation’s (Humanetics) new drug candidate, BIO 300, were presented at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29th in Kissimmee, Florida. MHSRS is the foremost scientific meeting of the U.S. Department of Defense (DOD), focusing on the unique medical needs of warfighters.
BIO 300 was originally developed as a radioprotectant by researchers at the Armed Forces Radiobiology Research Institute (AFRRI) in Bethesda, Maryland. It was exclusively licensed to Humanetics for advanced development and commercialization. Collaborative studies continue with DOD scientists to develop BIO 300 as an oral drug that warfighters can take to provide protection against the effects of radiation from a radiological or nuclear event.
Key Highlights of the Presentation:
- Novel Formulation: An overview of the BIO 300, an orally available drug designed for ease of use and rapid administration in various military and commercial settings.
- Efficacy and Safety: Insights into the nonclinical studies demonstrating the compound’s ability to protect against Acute Radiation Syndrome (ARS) and its safety in animal models.
- Clinical Development Pathway: An outline of clinical data supporting BIO 300’s safety and efficacy, including the proposed plan for human dose conversion under the FDA animal rule.
- Ongoing Development Activities: A detailed overview of ongoing and future development activities to support planned regulatory submissions.
This work highlighted on BIO 300 research has positioned it as one of the most advanced prophylactic medical countermeasures currently under development for ARS. Developing countermeasures that protect individuals, especially military personnel, against ARS is paramount, considering the current geopolitical environment fueling the real and increasing threat of nuclear or radiological events.
“We are thrilled to share our progress on the advanced development of BIO 300,” said Michael Kaytor, Ph.D., Vice President of Research and Development at Humanetics. “This drug could transform our ability to protect the men and women who serve our country, and anyone who may be at risk of intentional or accidental radiation exposure.”
In addition to its military applications, BIO 300 is being evaluated in phase 2 clinical trials to prevent normal tissue injury resulting from cancer radiotherapy and to reduce inflammatory lung damage (e.g., COVID-19, Idiopathic Pulmonary Fibrosis, acute respiratory distress syndrome).
The research presented was supported in part by grants from the US Department of Defense’s Congressionally Directed Medical Research Program and an Other Transaction Authority agreement with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND). The views expressed herein are those of Humanetics and may not reflect the official policy or position of the Department of Defense or the US Government. Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes.
About Humanetics Corporation
Humanetics Corporation is a clinical-stage pharmaceutical company engaged in the accelerated discovery, development and commercialization of proprietary drugs in markets with urgent and unmet needs with a focus on radiation modulators for oncology and medical countermeasures. For more information, visit www.humaneticscorp.com.
Contacts
Michael Kaytor
VP – Research and Development
mkaytor@humaneticscorp.com
