Elusys announces full enrollment in Phase 3 anthrax anti-toxin studies

Elusys Therapeutics, Inc., announced on Wednesday that it has completed enrollment in three Phase 3 clinical safety studies and one tolerability study of its ETI-204 anti-toxin treatment against inhalational anthrax.

ETI-204 is in the late stages of development and may enter into the Strategic National Stockpile, the U.S. government's collection of important medical supplies in the event of a biological threat emergency, if approved for use in the U.S.

"We are very pleased to have completed enrollment of our phase 3 clinical program which will provide further understanding of how ETI-204 can be used to help protect U.S. citizens in the event of biowarfare threat," Elusys President and Chief Executive Officer Elizabeth Posillico said. "Our clinical trials include over 400 adult study subjects. We look forward to completing our clinical development program and moving one step closer to BLA filing."

Anthrax is potentially fatal infectious disease caused by the Bacillus anthracis bacterium and is considered one of the nation's top biowarfare threats. In 2001, anthrax letter attacks led to a fatality rate of approximately 50 percent among victims that inhaled the virus, despite antibiotic treatment and hospitalization.

ETI-204 shows promise as a viable solution to anthrax inhalation. It is the only anthrax anti-toxin treatment in the late stages of development that is under investigation for potential use in IV treatment and IM prophylaxis administration, which could allow for faster, emergency administration outside of a hospital setting.