PINE BROOK, NJ, JULY 31, 2013 – Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, today released data from three recently completed studies of ETI-204 (Anthim) administered by intramuscular (IM) injection. ETI-204, an anthrax anti-toxin, is an investigational agent in late stage development for the treatment of inhalational anthrax infection.
Two of the studies assessed IM administration of ETI-204 following challenge with aerosolized B. anthracis spores (either before or after the development of symptoms of anthrax). A third study examined the potential protective effect of administering ETI-204 at various times prior to challenge with B. anthracis. All three studies were conducted in cynomolgus monkeys.
“These three recent studies demonstrate promising results of ETI-204 when given to anthrax exposed animals via intramuscular administration,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “ETI-204 could offer an important complement to the current anthrax countermeasures.”
The first study was a randomized, blinded, seven-arm, placebo-controlled, post-challenge, timed-treatment study. Animals were exposed to Bacillus anthracis spores and treated with a single dose of ETI-204 (8 or 16 mg/kg IM) at 18, 24 or 36 hours after challenge with aerosolized B. anthracis spores. The primary endpoint was survival at 28 days after challenge. Animals treated at 18 and 24 hours post-challenge demonstrated statistically significantly higher survival rates — 100% (6/6) and 83% (5/6), respectively — than control, regardless of ETI-204 dose. Animals treated with 8 mg/kg at 36 hours post-challenge succumbed to anthrax while the group treated with 16 mg/kg at that time point showed 50% (3/6) survival. All animals treated with placebo at 18 hours post-challenge succumbed to anthrax.
The second study was a randomized, four-arm, placebo-controlled, post-challenge, timed-treatment study. Animals were treated with a single dose of ETI-204 (16 mg/kg IM) at 24, 36 or 48 hours after challenge with aerosolized B. anthracis spores. The primary endpoint was survival at 28 days after spore challenge. The group treated with ETI-204 (16 mg/kg IM) 24 hours post-challenge demonstrated a survival rate of 93% (13/14) which was statistically significantly higher than the 10% (1/10) survival rate seen in the control group. The groups treated with ETI-204 at 36 or 48 hours post-challenge demonstrated survival rates of 43% (6/14) and 29% (4/14), respectively.
A planned secondary analysis revealed that 100% (15/15) of animals dosed with ETI-204 before becoming bacteremic (having evidence of bacteria in the blood stream) survived, and 30% (8/27) of animals dosed with ETI-204 after becoming bacteremic survived. These results were presented, in part, at the recent ASM Biodefense and Emerging Diseases Research Meeting, Washington, DC, February 2013.
A third study examined the pre-challenge protection duration of ETI-204. The study was a randomized, blinded, four-arm, placebo-controlled study in animals dosed with ETI-204 prior to challenge with B. anthracis spores. Animals were administered a single dose of ETI-204 (16 mg/kg IM) at either 24, 48 or 72 hours prior to challenge with aerosolized B. anthracis spores. The primary endpoint was survival at 56 days after challenge. All animals receiving ETI-204 survived to 56 days post-challenge, regardless of the time ETI-204 was administered prior to challenge. Ninety percent (9/10) of animals dosed with placebo prior to challenge died within the first 14 days following challenge with B. anthracis. All control animals developed bacteremia by 56 hours after challenge while 86% (36/42) of animals dosed with ETI-204 never developed detectable levels of bacteremia.
“These data demonstrate the considerable activity obtained with intramuscular (IM) administration of the anti-toxin when given either before or after challenge in animal models of inhalational anthrax. We are extremely pleased that a single dose of ETI-204 demonstrated protection against inhalational anthrax infection,” said Leslie Casey, PhD, Vice President, Research. “We look forward, in the very near term, to initiating a clinical study in healthy subjects to assess the pharmacokinetics and tolerability of IM administration in humans.”
Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation’s top biowarfare 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 the only anthrax anti-toxin in advanced stages of development that is formulated as a solution and is being investigated for both IV and IM administration. A product that can be given IM as well as IV is highly desirable because it could provide the capability to more rapidly administer product to people outside of a hospital setting or where IV administration is not feasible.
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 of inhalational anthrax. ETI-204 is formulated as a solution and is being evaluated for intravenous (IV) and/or intramuscular (IM) administration. ETI-204 efficacy and safety is being studied in animal models of inhalational anthrax and safety studies are being conducted with human volunteers. Three studies assessing pharmacokinetics and safety of intravenous (IV) administration of ETI-204 in humans have 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 countermeasures 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.
Elizabeth G. Posillico, PhD
President & CEO
SAFE HARBOR STATEMENT
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