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news.Elusys Therapeutics, a biopharmaceutical company, has initiated a second Phase I human safety trial of Anthim, a high-affinity humanized and deimmunized monoclonal antibody targeting the anthrax toxin protective antigen.
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The Phase I dose-escalation trial is planned to enroll 45 healthy volunteers and is designed to expand the human safety database.
The company also reported the results of a previously conducted animal efficacy study. A single dose of Anthim provided a significant survival benefit (up to 94% survival in treated rabbits versus 0% in controls) when administered to symptomatic rabbits. These results are consistent with several previous rabbit and primate studies that Elusys has conducted and show the protective effect of Anthim.
Elizabeth Posillico, president and CEO of Elusys, said: “We are extremely pleased with the success of our development program for Anthim. Our drug consistently demonstrates remarkable efficacy in treating anthrax infection in animal models and is a strong candidate for addition to the strategic national stockpile.”