Over 400 subjects participating in phase 3 studies
PINE BROOK, NJ, USA I February 5, 2014 I Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed enrollment in three phase 3 safety studies of ETI-204, an anti-toxin in development for the treatment of inhalational anthrax. Elusys also announced it has completed enrollment in an additional study to evaluate the tolerability and pharmacokinetics of intramuscular (IM) administration of ETI-204 in an additional 20 adult volunteers. ETI-204, in the late stages of development, is a potential target for future acquisition into the Strategic National Stockpile, the U.S. government’s repository of critical medical supplies for biowarfare preparedness.
The first double blind, randomized, placebo-controlled study is assessing the safety and tolerability of a single intravenous (IV) dose (16mg/kg) of ETI-204 in 280 adult volunteers. Subjects are being randomized in a 3:1 ratio, with 210 subjects receiving ETI-204 and 70 subjects receiving placebo. This study will also evaluate the bioavailability and clearance (pharmacokinetics), as well as the body’s immune response (immunogenicity) of the anti-toxin.
A second double blind, randomized, placebo-controlled study is evaluating the safety and tolerability of repeat IV administration of ETI-204 (16mg/kg) in 70 adult subjects, as well as the pharmacokinetics and immunogenicity of the anti-toxin. Study subjects are being randomized in a one-to-one ratio, to receive ETI-204 on days 1 and 14 and placebo on day 120 of the study, or ETI-204 on days 1 and 120 and placebo on day 14.
“We are very pleased to have completed enrollment of our phase 3 clinical program which will provide further understanding of how ETI-204 can be used to help protect U.S. citizens in the event of biowarfare threat,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “Our clinical trials include over 400 adult study subjects. We look forward to completing our clinical development program and moving one step closer to BLA filing.”
The company has also completed enrollment for a phase 3 study to assess the safety and tolerability of ETI-204 when given with oral ciprofloxacin, an antibiotic used to treat anthrax infection after inhalational exposure. Forty adult volunteers were randomized into two groups. The first group is receiving IV ETI-204 (16mg/kg) followed by a single dose of IV ciprofloxacin (400mg), followed by oral ciprofloxacin (750mg) every 12 hours on days two through eight and one final dose of the antibiotic on the morning of day nine. The second group is receiving IV ETI-204 alone.
A fourth study has enrolled 20 adult volunteers to evaluate the safety and tolerability of IM injection of ETI-204. Subjects have been randomized to receive either IM administration of ETI-204 at doses of 4mg/kg (4 subjects), 8mg/kg (8 subjects) or 16mg/kg (8 subjects), or matching placebo.
Inhalation 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 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 efficacy and safety are being studied in animal models of inhalational anthrax and safety studies are being conducted with healthy human volunteers. Three studies assessing safety and pharmacokinetics of IV administration of ETI-204 in adult volunteers 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 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.
SOURCE: Elusys Therapeutics
Post Views: 148
Over 400 subjects participating in phase 3 studies
PINE BROOK, NJ, USA I February 5, 2014 I Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed enrollment in three phase 3 safety studies of ETI-204, an anti-toxin in development for the treatment of inhalational anthrax. Elusys also announced it has completed enrollment in an additional study to evaluate the tolerability and pharmacokinetics of intramuscular (IM) administration of ETI-204 in an additional 20 adult volunteers. ETI-204, in the late stages of development, is a potential target for future acquisition into the Strategic National Stockpile, the U.S. government’s repository of critical medical supplies for biowarfare preparedness.
The first double blind, randomized, placebo-controlled study is assessing the safety and tolerability of a single intravenous (IV) dose (16mg/kg) of ETI-204 in 280 adult volunteers. Subjects are being randomized in a 3:1 ratio, with 210 subjects receiving ETI-204 and 70 subjects receiving placebo. This study will also evaluate the bioavailability and clearance (pharmacokinetics), as well as the body’s immune response (immunogenicity) of the anti-toxin.
A second double blind, randomized, placebo-controlled study is evaluating the safety and tolerability of repeat IV administration of ETI-204 (16mg/kg) in 70 adult subjects, as well as the pharmacokinetics and immunogenicity of the anti-toxin. Study subjects are being randomized in a one-to-one ratio, to receive ETI-204 on days 1 and 14 and placebo on day 120 of the study, or ETI-204 on days 1 and 120 and placebo on day 14.
“We are very pleased to have completed enrollment of our phase 3 clinical program which will provide further understanding of how ETI-204 can be used to help protect U.S. citizens in the event of biowarfare threat,” said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. “Our clinical trials include over 400 adult study subjects. We look forward to completing our clinical development program and moving one step closer to BLA filing.”
The company has also completed enrollment for a phase 3 study to assess the safety and tolerability of ETI-204 when given with oral ciprofloxacin, an antibiotic used to treat anthrax infection after inhalational exposure. Forty adult volunteers were randomized into two groups. The first group is receiving IV ETI-204 (16mg/kg) followed by a single dose of IV ciprofloxacin (400mg), followed by oral ciprofloxacin (750mg) every 12 hours on days two through eight and one final dose of the antibiotic on the morning of day nine. The second group is receiving IV ETI-204 alone.
A fourth study has enrolled 20 adult volunteers to evaluate the safety and tolerability of IM injection of ETI-204. Subjects have been randomized to receive either IM administration of ETI-204 at doses of 4mg/kg (4 subjects), 8mg/kg (8 subjects) or 16mg/kg (8 subjects), or matching placebo.
Inhalation 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 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 efficacy and safety are being studied in animal models of inhalational anthrax and safety studies are being conducted with healthy human volunteers. Three studies assessing safety and pharmacokinetics of IV administration of ETI-204 in adult volunteers 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 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.
SOURCE: Elusys Therapeutics
Post Views: 148
