Humanetics Corporation Announces Results from Phase 1 Trial of BIO 300 Oral Powder
BIO 300 Oral Powder was safe and well-tolerated in a clinical trial of 34 healthy volunteers.
Minneapolis, MN – Humanetics Corporation (Humanetics) announced today that it has completed a phase 1 trial of the Company’s medical countermeasure for acute radiation syndrome (ARS), BIO 300 Oral Powder (NCT04650555). The trial was conducted at Nucleus Network, LLC (St. Paul, MN) and successfully enrolled 34 healthy volunteers. The goal of the trial was to evaluate the safety, pharmacokinetics and pharmacodynamics of BIO 300 Oral Powder, which is under development for use by military and first responders to allow them to operate in areas of known or potential risk of radiation exposure. This trial was funded by the U.S. Department of Defense’s Joint Warfighter Medical Research Program.
Trial participants were administered either a single ascending dose, or a six-day course where participants received daily doses for six consecutive days. BIO 300 Oral Powder was found to be safe and well-tolerated at daily doses up to 3000mg. The pharmacokinetics of BIO 300 Oral Powder demonstrated targeted levels of therapeutic drug exposure with no dose-dependent toxicities. Results from this trial will support identification of an efficacious human dose to increase survival in persons exposed to lethal levels of radiation, which is required for drug approval under the U.S. Food and Drug Administration Animal Rule. At present, there are no FDA-approved prophylactic medical countermeasures to prevent or reduce the incidence of ARS for warfighters and first responders exposed to radiation.
BIO 300 Oral Powder is a new solid dosage formulation designed for ease of use in the field by military personnel and first responders. BIO 300 is based on research conducted by the United States Department of Defense, which has granted worldwide exclusive rights to Humanetics for the continued development of the drug as a medical countermeasure for radiation exposure. BIO 300 has unique biological properties that allow it to be used prophylactically to prevent the detrimental hematological effects of lethal radiation exposure. BIO 300 was recently granted Fast Track designation by the U.S. Food and Drug Administration for its use to improve survival in patients exposed to myelosuppressive doses of radiation.
BIO 300 has also shown the ability to mitigate inflammation of the lungs (pneumonitis) and pulmonary fibrosis caused by thoracic radiation exposure. Radiation-induced lung injury is similar to the toxicities associated with lung cancer radiotherapy, and to lung injury caused by COVID-19. Humanetics has further expanded applications for the drug into cancer radiotherapy and COVID-19. Humanetics recently completed a clinical trial of BIO 300 in combination with chemoradiotherapy in patients with locally advanced lung cancer (NCT02567799) and is currently enrolling a clinical trial in patients with COVID-19 recently discharged from the hospital who are at risk of developing long-term pulmonary complications (NCT04482595).