Anthrasil (AIGIV) / Emergent Biosolutions - LARVOL DELTA

Dust to Dawn: A Case of Complicated Silicosis With Progressive Massive Pulmonary Fibrosis (ATS 2024) - "He ultimately underwent a surgical lung biopsy of his right middle lobe revealing multiple non-caseating anthrasilicotic granulomas that were negative for AFB, fungal stains and crystals on polarization...Despite being on maintenance prednisone in combination with maximal inhaler therapy for many years he has had symptomatic worsening...Our case demonstrates an infrequent but largely preventable disease with a poor prognosis. A thorough occupational history and chest imaging are diagnostic tools available for the diagnosis of silicosis with lung biopsy reserved for instances where a clinical diagnosis cannot be made."

Clinical • Fatigue • Fibrosis • Immunology • Infectious Disease • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax (clinicaltrials.gov) - P=N/A | N=10 | Not yet recruiting | Sponsor: Emergent BioSolutions | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date

A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Emergent BioSolutions | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date

Animal-to-Human Dose Translation of ANTHRASIL for Treatment of Inhalational Anthrax in Healthy Adults, Obese Adults, and Pediatric Subjects. (PubMed, Clin Pharmacol Ther) - "Additional simulations suggest that exposure levels were similar in healthy and obese humans, and exposure in pediatrics is expected to be up to approximately seven-fold higher than in healthy adults, allowing for doses in pediatric populations that ranged from one to seven vials. Overall, the optimal human dose was justified based on the PK/pharmacodynamic (PD) properties of AIGIV in animals and model-based translation of PK/PD to predict human exposure and efficacy."

Journal • Obesity • Pediatrics

Efficacy of ANTHRASIL (Anthrax Immune Globulin Intravenous (Human)) in rabbit and nonhuman primate models of inhalational anthrax: Data supporting approval under animal rule. (PubMed, PLoS One) - "Similarly, ANTHRASIL was effective in cynomolgus monkeys (N = 16/group) when administered therapeutically after the onset of toxemia, with 6% survival in the IGIV control and a dose-related increase in survival of 36%, 43%, and 70% with 7.5, 15 or 30 U/kg doses of ANTHRASIL, respectively. These studies formed the basis for approval of ANTHRASIL by FDA under the Animal Rule."

Journal • Preclinical

Pre- and Postlicensure Animal Efficacy Studies Comparing Anthrax Antitoxins. (PubMed, Clin Infect Dis) - "These data illustrate the relative therapeutic benefit of the 3 antitoxins and provide a rationale to prioritize their deployment."

Journal

Pre- and Postlicensure Animal Efficacy Studies Comparing Anthrax Antitoxins. (PubMed, Clin Infect Dis) - "These data illustrate the relative therapeutic benefit of the 3 antitoxins and provide a rationale to prioritize their deployment."

Journal

A Review of the Efficacy of FDA-Approved B. anthracis Anti-Toxin Agents When Combined with Antibiotic or Hemodynamic Support in Infection- or Toxin-Challenged Preclinical Models. (PubMed, Toxins (Basel)) - "At present, three anthrax anti-toxin antibody preparations have received US Food and Drug Administration (FDA) approval: Raxibacumab, Anthrax Immune Globulin Intravenous (AIGIV) and ETI-204. To provide a broader view of the potential effectiveness of these agents, this review examines the controlled preclinical experience either in antibiotic-treated B. anthracis models or in titrated hemodynamic-supported toxin-challenged canines. The strength and weaknesses of these preclinical experiences are discussed."

FDA event • Journal • Review • Septic Shock

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax (clinicaltrials.gov) - P=N/A; N=10; Not yet recruiting; Sponsor: Emergent BioSolutions

New trial • Biosimilar

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax (clinicaltrials.gov) - P=N/A; N=10; Not yet recruiting; Sponsor: Emergent BioSolutions; Initiation date: Aug 2018 ➔ Aug 2019

Clinical • Trial initiation date

A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients (clinicaltrials.gov) - P=N/A; N=100; Not yet recruiting; Sponsor: Emergent BioSolutions; Initiation date: Aug 2018 ➔ Aug 2019

Clinical • Trial initiation date