Elusys files to begin human anthrax studies

Anthim is a therapeutic monoclonal antibody being developed by Elusys to prevent and treat anthrax infections.

Following clearance of the investigational new drug (IND) by the FDA, Elusys will initiate a phase I placebo-controlled trial of Anthim in healthy adult volunteers. The trial will examine the safety, tolerability and pharmacokinetics of Anthim.

“Based upon very significant and promising safety and efficacy data we have obtained with Anthim in animals, we are ready to test the safety of the drug in human volunteers,” said Dr Linda Nardone, vice president of clinical and regulatory affairs at Elusys. “Following our safety studies, Anthim could be made available in the event it is ever required for a national emergency.”

Animal studies have demonstrated that a single, low dose of Anthim is 100% effective when given prophylactically, prior to anthrax exposure, and greatly increases survival when given up to two days after anthrax exposure.

Importantly, Anthim is equally effective when delivered by intramuscular injection and thus has the advantage that it can be rapidly given to civilians in an emergency situation. Anthim is the only monoclonal antibody under development that has been demonstrated to protect animals from death when delivered intramuscularly.