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PRESS RELEASE 2014

ELUSYS REPORTS ITS ANTI-TOXIN ACHIEVED 100% SURVIVAL RATE FOLLOWING ANTHRAX CHALLENGE IN PRE-TREATMENT ANIMAL STUDY

Company presents data from four research studies at ASM Biodefense conference

PINE BROOK, NJ, January 30, 2014 – Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, presented data demonstrating that ETI-204, its anti-toxin in development for the treatment of inhalational anthrax, was 100% effective in protecting monkeys from death due to anthrax when administered via intramuscular (IM) injection up to 72 hours prior to anthrax exposure. Study results were discussed in a podium presentation at the ASM Biodefense and Emerging Diseases Research meeting being held this week in Washington, DC. ETI-204 is completing phase III development, and is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government’s repository of critical medical supplies for biothreat preparedness.

In this blinded study, a single dose of ETI-204 (16 mg/kg) was administered via IM injection to 14-15 cynomolgus monkeys per group at 24, 48 or 72 hours prior to challenge with aerosolized B. anthracis spores. Ten monkeys received placebo only as control. ETI-204 dosed IM 24, 48 or 72 hours before spore challenge protected 100% of the animals (43/43) through 56 days post anthrax exposure. Control survival rate was 10% (1/10), and all control monkeys were bacteremic between 24 and 54 hours post challenge. The majority of ETI-204 dosed monkeys (86%; 37/43) never became bacteremic (had no evidence of bacteria in the blood stream). A few ETI-204-dosed monkeys (14%; 6/43) developed transient low-level bacteremia that resolved by seven days post-challenge.

“Achieving 100% survival with ETI-204 administered as a prophylactic, with no disease re-emergence and all survivors observed to be spore-free in all tissues examined at day 56 post-challenge is highly encouraging,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys.

Two poster presentations delivered by Elusys at the ASM Biodefense conference highlighted the survival rates of ETI-204 in combination with antibiotics, as well as its effect on CNS toxicity:

  • Twenty rabbits per group were aerosol challenged with B. anthracis spores and re-challenged nine months later. Therapeutic dosing of ETI-204, levofloxacin (a common antibiotic used in treating anthrax infection), or a combination of ETI-204 and levofloxacin was administered 30 hours post primary challenge, and no additional treatment was given at re-challenge. A group of eight and 12 age-matched naïve controls was included with the primary and secondary challenge, respectively. Following primary challenge, survival rates were 65% (ETI-204; 13/20), 100% (levofloxacin; 20/20), and 95% (ETI-204/levofloxacin combination; 19/20). Following secondary challenge, survival rates were 100% (ETI-204; 13/13), 95% (levofloxacin; 19/20), and 89% (ETI-204/levofloxacin combination; 17/19). No controls survived. In the majority of animals surviving re-challenge, systemic bacteremia, and toxemia were not detected. This study demonstrated that ETI-204, alone or in combination with antibiotics, significantly improves survival compared to control and does not interfere with the development of protective immunity.
  • Cynomolgus macaques were aerosol challenged with B. anthracis spores and treated with a single intravenous (IV) dose of ETI-204 (4-32 mg/kg) or saline in three studies. Brain tissue samples from surviving and non-surviving animals (15 sections/brain) were examined and bacterial presence was assessed. There were no significant microscopic findings in brain tissues of ETI-204-treated survivors in all studies. In ETI-204-treated non-survivors, observations of acute inflammation were comparable but occurred with greater frequency in ETI-204-treated compared to placebo-treated animals (p<0.05) which was primarily associated with the presence of bacteria in the brain. Frequency of microscopic findings in brains of ETI-204 treated non-survivors did not exhibit a dose response relationship. This retrospective analysis suggests that ETI-204 has no direct CNS toxicity. Exacerbated inflammation in ETI-204-treated non-survivors may have been an indirect result of immune activation due to neutralization of toxin.

“These data demonstrate that ETI-204, both alone or in combination with antibiotics, can significantly improve survival compared to control and suggest that ETI-204 has no direct effect on CNS toxicity,” added Posillico.

In a third poster presentation, Elusys reported on research characterizing the performance and reliability of a method for measuring quantitative bacteremia as a disease progression marker in animal studies after B. anthracis spore challenge and ETI-204 treatment. Linearity, stability and interference results suggest this method of measuring bacterial counts is suitable for use and may prove to be an effective way to measure disease progression in anthrax challenge studies.

Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation’s top bioterror threats. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics. In the 2001 anthrax letter attacks, inhalational anthrax had a fatality rate of approximately 50% in humans infected even when victims were given antibiotics and supportive hospital care.

ETI-204 is formulated as a solution and is the only anthrax anti-toxin in advanced stages of development that is being investigated for IV treatment and IM prophylaxis administration. A product that can be given via IM injection is highly desirable because it could provide the capability to more rapidly administer product to people outside of a hospital setting or when IV administration is not feasible.

About ETI-204

ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen. It is an investigational agent being developed for treatment and prophylaxis of inhalational anthrax. ETI-204 is formulated as a solution and is being evaluated for intravenous (IV) and/or intramuscular (IM) administration.

ETI-204 is currently undergoing three double blind, randomized, placebo-controlled safety and tolerability studies with nearly 400 adult volunteers. Three studies assessing pharmacokinetics and safety of IV administration of ETI-204 in humans have already been completed. The more common adverse events related to ETI-204 administration across the three studies included upper respiratory tract infection, nausea, headache, nasal congestion and erythema. ETI-204 was granted Fast Track status and Orphan Drug Designation by the FDA.

This program is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS) under Contract Nos. HHSO100201000026C and HHS0100201100034C.

About Elusys Therapeutics, Inc.

Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. Elusys has been engaged in the development of ETI-204, an anthrax biowarfare countermeasure since 2000. The company has received multiple grants and contracts totaling over $200 million to support the development of ETI-204 to protect people in the event of an anthrax attack. Today, ETI-204 has advanced to the final stages of development, and is closer to achieving the company’s goals of receiving FDA licensure and becoming part of the Strategic National Stockpile. For more information, please visit www.elusys.com.

CONTACT:

Gail D’Alessandro
Elusys Therapeutics, Inc.
t: 973.808.0222
gdalessandro@elusys.com

SAFE HARBOR STATEMENT

This announcement includes statements that are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. This release includes forward looking statements. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management that are subject to risks, uncertainties and other important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements. The guidance in this presentation is only effective as of the date given and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance.

Elusys Reports Its Anti-toxin Achieved 100% Survival Rate Following Anthrax Challenge In Pre-treatment Animal Study

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