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news.Elusys Therapeutics fast-tracked anthrax antibody therapeutic, Anthim, has been shown to be well tolerated with a favorable safety profile in a phase I study.
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Anthim is being developed under the FDA animal rule, a regulatory process specifically designed for the development of medical countermeasures to bioterror threats. According to this rule, marketing approval of Anthim can be granted based on efficacy in relevant animal models with an acceptable safety risk profile in humans.
The study was designed to determine the safety and tolerability of Anthim in healthy volunteers, when administered with or without the antibiotic ciprofloxacin which is the chemical name for Bayer Pharmaceutical’s brand antibiotic, Ciproxin.
“The successful completion of this human clinical study is an important milestone for Anthim,” commented Dr Elizabeth Posillico, president & CEO of Elusys Therapeutics. “This impressive safety data, combined with its published efficacy data, makes Anthim a valuable anthrax countermeasure for the US Government’s strategic national stockpile under Project BioShield.”