Elusys Therapeutics' Anthrax drug candidate is to commence human clinical trials after the biopharmaceutical company received Institutional Review Board (IRB) approval. The drug, which has already received "Fast Track" approval, is expected to begin tests in the coming weeks.
The 2001 anthrax attacks in which five people died despite aggressive treatment with antibiotics demonstrate the urgent need for a well-tolerated, single-dose treatment that disrupts anthrax toxins.
When people are exposed in an anthrax attack, antibiotic treatment alone is not enough. Vaccination takes a long time to achieve protection, and it is the toxins, not the bacteria, that kill.
The drug, 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.
A single dose of Anthim has been shown to be 100 per cent effective when administered as a prophylactic (prior to anthrax exposure) and dramatically increases survival rates when given up to 48 hours after exposure.
Anthim's low dose will allow for intramuscular (IM) delivery, the most effective mode of delivery to both military and civilian personnel in emergency situations.
Anthim is to undergo Phase 1, randomised, placebo-controlled, double blind, dose- escalation study designed to determine the safety, tolerability and pharmacokinetics of a single dose of Anthim in healthy volunteers.
"Elusys has been working with the US Government on Anthim and has successfully developed a therapeutic that can be delivered intramuscularly in an emergency situation," said Elizabeth Posillico, president & CEO of Elusys Therapeutics.
The initiation of this Phase 1 study positions Anthim closer to potential purchase by the US Government under Project BioShield. Elusys Therapeutics has initiated commercial manufacturing scale-up to make Anthim available for the Strategic National Stockpile.
Anthim is being developed under The Food and Drug Administration (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.
The company was recently awarded $4.4 million (€3.7 million) from the National Institute of Allergy and Infectious Diseases (NIAID) and $1 million from the Department of Defense for advanced development.
To date, the Company has been awarded $20M from the US Government for the development of novel therapeutics to combat bioterror agents.
In February 2004, Elusys responded to a DHHS Request for Information (DHHS 65-RFI) for Antibody Treatments for Anthrax. The Office of Research and Development Coordination, as a prelude to procurement of therapeutics for the treatment of anthrax, issued a second DHHS RFI in March.
Spores of the bacterium Bacillus anthracis cause anthrax. B. anthracis is considered to be one of the top (CDC Category A) biothreat agents by the US government. The bacteria secrete toxins that paralyze the immune system, damage tissues and lead to death.