PINE BROOK, N.J.—Biopharmaceutical company ElusysTherapeutics, Inc., which specializes in developing biodefense countermeasures,has announced that the U.S. government has awarded it a contract to develop ananti-toxin for pre-and post-exposure prophylaxis (PEP) use via intramuscularinjection. The contract will run five years, and will provide up to $68.9million in funding to support multiple animal efficacy studies and human safetystudies regarding the effectiveness of Anthim (ETI-204), Elusys' anti-toxin.
The anti-toxin is manufactured to prevent disease and deathresulting from anthrax exposure when it is administered intramuscularly beforethe onset of symptoms. Intramuscular administration has several benefits overintravenous administration, particularly in the lack of personnel andpreparation required and the speed at which it allows for delivery of theanti-toxin.
"Many more people can quickly receive prophylactic treatmentagainst anthrax infection using intramuscular administration, particularly inan emergency setting before symptoms are present," Elizabeth Posillico, Ph.D.,President and Chief Executive Officer of Elusys, said in a press release. "Inseveral animal studies conducted to date, ETI-204 has demonstrated excellentefficacy and increased survival significantly when given in a singleintramuscular dose. We are pleased to continue the advanced development ofAnthim for prophylactic therapy against anthrax toxemia."
Anthim is a high-affinity, humanized and deimmunizedmonoclonal antibody that works by targeting the protective antigen of Bacillusanthracis, the bacteria that causes anthrax, and neutralizing anthrax's lethaleffects. The anti-toxin has been shown to be an effective therapeutic, with asingle dose consistently protecting 70 to 100 percent of anthrax-infected testanimals from death. Two safety studies have already been completed in humanswith Anthim, and it has received Fast-Track status as well as Orphan DrugDesignation from the U.S. Food and Drug Administration (FDA).
"In a recent animal study, a single IM dose of Anthimprovided a 92 percent survival rate when administered 18 hours after exposureto anthrax," Leslie Casey, PhD, Vice President of Research, noted in a pressrelease. "All surviving animals tested negative for anthrax bacteria by studyday 14. The results of this study, in addition to other animal studiespreviously conducted by the company, continue to demonstrate the significantsurvival benefit of ETI-204 when given to anthrax exposed animals."
The research was funded by the U.S. Department of Defense,Joint Program Executive Office for Chemical and Biological Defense.
If the development for ETI-204 goes as planned and iscompleted to the satisfaction of the FDA, the U.S. government could end uppurchasing Anthim for the Strategic National Stockpile under Project BioShield,which was established in 2004 to provide funding for the discovery anddevelopment of medical countermeasures in the event of a bioterrorism threat orattack.
This funding supplements an additional contract, one whichtotals up to $143 million over the span of five years and was awarded for thedevelopment of Anthim as a treatment for symptomatic patients. The funding willbe provided by the Biomedical Advanced Research and Development Authority(BARDA), within the Office of the Assistant Secretary for Preparedness andResponse in the U.S. Department of Health and Human Services.
SOURCE: Elusys Therapeutics press release