PINE BROOK, N.J., July 20, 2016 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) today announced that two important manuscripts describing animal efficacy of ANTHIM (obiltoxaximab) Injection in treatment and prophylaxis of inhalational anthrax have been accepted for publication by Antimicrobial Agents and Chemotherapy. The supporting studies were conducted during development of ANTHIM, which received FDA marketing approval in March 2016. In November 2015, Elusys was awarded a $45M delivery order from the U.S. government to produce ANTHIM for the U.S. Strategic National Stockpile (SNS), the U.S. government's repository of critical medical supplies for public health emergency preparedness. ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.
The first publication, "Obiltoxaximab for Inhalational Anthrax: Efficacy Projection Across a Range of Disease Severity," describes the protective efficacy of obiltoxaximab in a series of treatment studies conducted in animal models.
The second paper, "Obiltoxaximab Prevents Disseminated Bacillus anthracis Infection and Improves Survival during Pre- and Post-Exposure Prophylaxis in Animal Models of Inhalational Anthrax," describes efficacy of obiltoxaximab in the settings of both pre‑exposure prophylaxis and post-exposure prophylaxis in animal models.
Because it is not feasible or ethical to conduct controlled clinical trials in humans with inhalational anthrax, the efficacy of ANTHIM for the treatment of inhalational anthrax is based on efficacy studies in two animal models. The animal efficacy studies are conducted under widely varying conditions, such that the survival rates observed in the animal studies cannot be directly compared between studies and may not reflect the rates observed in clinical practice.
"The papers are a culmination of many years of effort by our scientists and external collaborators and reflect a thorough investigation across the broad spectrum of inhalational anthrax disease in animal models," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "We are pleased to now share with the scientific community our extensive knowledge and understanding of obiltoxaximab's mechanism of action and potential usefulness in the treatment or prophylaxis of inhalational anthrax."
Manuscripts of the studies are currently accessible from the 'AAC Accepts' feature of the Antimicrobial Agents and Chemotherapy website and will be published in the October issue of the journal. To see the manuscripts on ACC Accepts (Brent J. Yamamoto et al.), click here.
ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM's toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for intravenous (IV) infusion.
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.
IMPORTANT SAFETY INFORMATION
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Premedication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.
USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population. To see the complete prescribing information for ANTHIM, click here.
The ANTHIM program was supported primarily 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 numbers 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. In March 2016, the U.S. Food and Drug Administration (FDA) approved ANTHIM (obiltoxaximab) Injection, the company's monoclonal antibody (mAb) anthrax antitoxin, for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Elusys has received over $240 million in development grants and contracts from the U.S. Department of Defense (DoD), National Institutes of Health (NIH) and BARDA. Current investors include Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures, MedImmune Ventures and Pfizer. For more information, please visit www.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.