Anthim was granted fast track status by the FDA on May 6th 2005, and this study will begin in the coming weeks.
The company has also initiated manufacturing scale-up to produce Anthim in commercial quantities in the event of US government purchase for the strategic national stockpile.
This phase I, randomized, placebo-controlled, double blind, dose- escalation study is designed to determine the safety, tolerability and pharmacokinetics of a single dose of Anthim in healthy volunteers.
Elizabeth Posillico, president & CEO of Elusys Therapeutics commented on today’s announcement, “Elusys has been working closely with the US government on Anthim and has successfully developed a potent and effective therapeutic that can be delivered intramuscularly in an emergency situation. We are confident that we have developed a product that will effectively meet the nation’s needs.”
Anthim is being developed under 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 only phase I safety trials required in humans.
Anthim is a high-affinity monoclonal antibody that targets the protective antigen component of anthrax, blocking the bacteria’s ability to form deadly toxins. In preclinical studies, Anthim has demonstrated efficacy at lower doses than other drugs in development.
Elusys was recently awarded $4.4 million from the National Institute of Allergy and Infectious Diseases and $1 million from the Department of Defense for advanced development. To date, the company has been awarded $20 million from the US government for the development of novel therapeutics to combat bioterror agents.