Company Overview of Elusys Therapeutics, Inc.
Elusys Therapeutics, Inc. is a biopharmaceutical company that focuses on the development of antibody therapeutics for the treatment of a life-threatening infectious disease. The company offers Anthim, an anti-toxin antibody for the treatment and prophylaxis of inhalational anthrax disease following a biowarfare attack. Its Anthim targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to protective antigen. Elusys Therapeutics, Inc. was formerly known as ErythroMed, Inc. The company was founded in 1998 and is based in Pine Brook, New Jersey.
25 Riverside Drive
Pine Brook, NJ 07058
Founded in 1998
Key Executives for Elusys Therapeutics, Inc.
Chief Executive Officer, President and Director
Senior Director of Human Resources & Administration
Vice President of Corporate Development
Vice President of Development and Manufacturing
Vice President of Regulatory Affairs
Compensation as of Fiscal Year 2015.
Elusys Therapeutics, Inc. Key Developments
U.S. Food And Drug Administration Accepts Biologics License Application for Anthim of Elusys Therapeutics, Inc
Jun 1 15
Elusys Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for filing and review its Biologics License Application (BLA) for Anthim (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. Anthim has been developed under Fast-Track status and Orphan Drug Designation by the FDA. 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. Under current guidelines, CDC recommends the use of anthrax antitoxins with antibiotics in cases where there is a high level of clinical suspicion for systemic anthrax. The filing acceptance is based on submission of efficacy data studied in animal models of inhalational anthrax and safety data from 350 healthy human volunteers receiving the proposed human therapeutic dose of Anthim administered intravenously. Anthim is a high-affinity monoclonal antibody in development for the treatment and prevention of inhalational anthrax, a top bioterror threat. Anthim is formulated as a solution and is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment and intramuscular (IM) prophylaxis administration. IV administration is being evaluated for the treatment of patients who have established infection and are symptomatic for anthrax disease, as well as for prophylaxis. Prophylaxis includes immediate pre-exposure prophylaxis (as in the case of emergency personnel responding to an event) and post-exposure prophylaxis (when there is reason to believe a person may have been exposed to anthrax but prior to signs/symptoms of infection).
Elusys Therapeutics, Inc. Reports Efficacy of its Anthrax Anti-Toxin in Post-Exposure Prophylaxis in Animal Studies
Feb 12 15
Elusys Therapeutics, Inc. presented data demonstrating that obiltoxaximab (ETI-204) demonstrated a statistically significant survival benefit across a range of disease severity in animal model studies assessing treatment of inhalational anthrax, as well as effectiveness in post-exposure prophylaxis. Obiltoxaximab is the company's investigational monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax used in a bioterror attack. Study results were highlighted in poster presentations at the ASM Biodefense and Emerging Diseases Research meeting in Washington, DC. Obiltoxaximab is in late stage development, and is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. In the first presentation, results of four studies conducted in a monkey treatment model of inhalational anthrax were discussed; survival to 28 days was the primary endpoint. There was significant survival for the majority of obiltoxaximab treatment groups (5/8) over placebo groups (p<0.025). Statistically significant obiltoxaximab survival benefit versus placebo were demonstrated across a range of disease severity. Survival outcomes were shown to be dependent on severity of disease prior to treatment as measured by the amount of bacteria in the blood; 16 mg/kg of ETI-204 was determined to be the maximally efficacious dose. A second presentation by Elusys demonstrated significant efficacy in two studies in monkeys. In both studies, obiltoxaximab was dosed via a single intramuscular injection (IM) at 16 mg/kg, 18-48 hours following challenge with aerosolized B. anthracis spores. Survival to day 28 or day 56 was the primary endpoint. In the first study, obiltoxaximab survival was 100%, 83% and 50% at 18, 24 and 36 hours compared to zero survival in the placebo group. In the second study, obiltoxaximab survival was 93%, 43%, and 25% at 24, 36 and 48 hours compared to 10% in placebo. IM obiltoxaximab was significantly efficacious compared to placebo when given at 18 and 24 hours post-exposure, and provided increased protection compared to controls at 36 and 48 hours post-exposure. Obiltoxaximab prevented development of Protective Antigen (PA) toxemia and bacteremia in the majority of animals when administered at 18 or 24 hours post challenge, and effectively neutralized serum PA in animals treated at 36 and 48 hours post challenge.
Elusys Therapeutics, Inc. Announces Results from Three Phase 3 Safety Studies of its Anthrax Anti-Toxin, Obiltoxaximab (ETI-204)
Sep 22 14
Elusys Therapeutics, Inc. announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204). Obiltoxaximab is an anti-toxin in development for the treatment of inhalational anthrax and data from these studies support the safety and tolerability of the antitoxin when administered intravenously (IV) at the intended therapeutic dose. The conclusion of these studies marks the completion of Elusys' Phase 3 clinical development program required for filing a biologics license application. Elusys also announced it has completed an additional dose escalation study to evaluate intramuscular (IM) administration of obiltoxaximab. Obiltoxaximab 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 study was a double-blind, randomized, placebo-controlled expanded safety study that evaluated the safety and tolerability of a single intravenous (IV) dose (16mg/kg) of obiltoxaximab in healthy men and women greater than or equal to 18 years of age. The study enrolled 280 healthy adult subjects and was conducted at four sites in the US. Subjects were randomized upon entry to receive either obiltoxaximab (210 subjects) or placebo (70 subjects). Most adverse events (AEs) reported during the study were mild to moderate in severity. The most frequently reported AEs related to obiltoxaximab were pruritus (itching) and headache. Approximately 5% of subjects in the obiltoxaximab group experienced AEs consistent with hypersensitivity reactions. The most frequently reported hypersensitivity events were pruritus, rash and urticaria. A second trial was a double blind, randomized, placebo-controlled study that evaluated the safety and tolerability of repeat IV administration of obiltoxaximab (16mg/kg) in 70 healthy volunteers. The study was conducted at two sites in the US. Adult men and women greater than or equal to 18 years of age were randomly placed into one of two different treatment groups upon entry: Group A (35 subjects) received obiltoxaximab on days 1 and 14 and placebo on day 120 of the study; Group B (35 subjects) received obiltoxaximab on days 1 and 120 and placebo on day 14. Most adverse events reported during the study that were considered related to obiltoxaximab were mild to moderate in severity. The most frequently reported AEs considered related to obiltoxaximab were infusion site swelling, infusion site erythema, and infusion site pain. There was no increase in the number AEs related to obiltoxaximab with repeat administration of obiltoxaximab, whether the second dose was administered 14 days or 120 days after the first dose. There were no serious adverse events related to obiltoxaximab administration reported in this study. The company has also completed an open label, randomized, parallel group drug-drug interaction study to assess the safety and tolerability of obiltoxaximab when given with ciprofloxacin, an antibiotic used to treat anthrax infection after inhalational exposure. Forty healthy males and females between 18 years to 65 years of age were enrolled at one center in the US. The subjects were randomized to one of two treatments: Group 1 (20 subjects) received IV obiltoxaximab (16mg/kg) followed by a single dose of IV ciprofloxacin (400mg), followed by oral ciprofloxacin (750mg) every 12 hours starting on day 2 until the morning of day 9; Group 2 (20 subjects) received IV obiltoxaximab (16mg/kg) alone. All AEs reported during the study that were considered related to obiltoxaximab were mild to moderate in intensity. The most frequently reported AE related to obiltoxaximab was urticaria (hives). Ciprofloxacin had no effect on the pharmacokinetics of obiltoxaximab, and the frequency of adverse events did not appear to increase with co-administration of obiltoxaximab and ciprofloxacin. There were no serious adverse events related to obiltoxaximab administration reported in this study.
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