AVP-21D9 is presently in a randomised, double-blind, placebo-controlled, dose escalation Phase I clinical study involving 50 healthy volunteers designed to evaluate the safety and pharmacokinetics of the product candidate.
Emergent BioSolutions president and chief operating officer Daniel Abdun-Nabi said that receiving FDA Orphan Drug Designation for the investigational monoclonal antibody underscores the unmet medical need in treating inhalation anthrax disease.
"We also fully support the US government’s preparedness efforts against the threat of anthrax as a biological weapon through continuing to manufacture and deliver doses of BioThrax, the only vaccine licensed by the FDA for the prevention of anthrax infection, into the strategic national stockpile, Abdun-Nabi said.