Elusys Therapeutics has been awarded additional funding from the U.S. Government, valued at $50.2 million, for the advanced development of ETI-204 (Anthim), an investigational agent for the treatment of anthrax infection following a biowarfare attack. ETI-204 is an investigational antitoxin and is a potential candidate for the treatment of inhalational anthrax in humans.
The $50.2 million awarded by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, will be used to conduct definitive efficacy studies in animals and complete validation of the commercial manufacturing process for ETI-204.
This third year of funding is in addition to $57.5 million the company already received under this contract and is part of a five-year award totaling up to $143 million. This advanced product development contract is supporting Elusys’ efforts to gain FDA licensure, including manufacturing activities, human safety trials, and nonclinical effectiveness studies in animals.
“We recently completed a clinical dose-escalation study and look forward to reviewing those data,” said Elizabeth Posillico, Ph.D., president and CEO of Elusys. The company’s dose-escalation study, including a total of 108 human subjects, collected additional safety and pharmacokinetic (PK) data at doses up to 16 mg/kg, administered intravenously.
Elusys has completed two other dose-escalation safety studies in humans and a number of studies assessing activity of ETI-204 against anthrax in two animal species. In the two completed studies the adverse event profile of ETI-204 was comparable to placebo, and the more common adverse events related to ETI-204 administration were headache and upper respiratory tract infection.
ETI-204 is formulated as a solution suitable for either IV or intramuscular (IM) administration. Because the anthrax antitoxin medication can be administered by conventional injection, it could make administration easier and thus potentially increase the number of people who could be vaccinated against this often fatal infection.
If all activities in the ETI-204 development program are completed to FDA’s satisfaction, the federal government could purchase ETI-204 for the Strategic National Stockpile (SNS) under Project BioShield. Project BioShield was established in 2004 to provide much needed funding to procure important countermeasures to protect the American public in the event of a biowarfare attack. ETI-204 was granted fast-track status and orphan drug designation in 2006 by the FDA.