Elusys Therapeutics concludes study on anthrax antitoxin

Elusys Therapeutics, Inc., announced on Monday that it has completed a three-phase study on an antitoxin in development to treat anthrax.

Conducted on adult volunteers, the study aimed to explore the "safety and tolerability of the antitoxin when administered intravenously at the intended therapeutic dose." With the completion of the study, Elusys now qualifies to file for a biologics license application.

"We are very pleased to have completed our Phase III clinical program, which will provide further understanding of how obiltoxaximab [the antitoxin] can be used to help protect U.S. citizens in the event of a biowarfare event," Elizabeth Posillico, the president and CEO of Elusys, said.

The first two parts of the study were both double-blind, randomized, placebo-controlled studies evaluating the tolerability of obiltoxaximab. The first part studied the effects of a one-time injection in 280 healthy individuals while the second explored the effects of repeat administration in 70 healthy individuals. The final portion of the study assessed how the antitoxin's interaction with other drugs.

"The results from these three trials are consistent with findings from previous clinical studies of IV obiltoxaximab and together present a robust safety and tolerability profile for inclusion in our upcoming BLA filing," Posillico said.

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Elusys Therapeutics

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