Therapeutic efficacy of equine botulism heptavalent antitoxin against all seven botulinum neurotoxins in symptomatic guinea pigs

PLoS One. 2019 Sep 17;14(9):e0222670. doi: 10.1371/journal.pone.0222670. eCollection 2019.

Abstract

Botulism neurotoxins are highly toxic and are potential agents for bioterrorism. The development of effective therapy is essential to counter the possible use of these toxins in military and bioterrorism scenarios, and to provide treatment in cases of natural intoxication. Guinea pigs were intoxicated with a lethal dose of botulinum neurotoxin serotypes A, B, C, D, E, F or G, and at onset of the clinical disease intoxicated animals were treated with either BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine)] or placebo. BAT product treatment significantly (p<0.0001) enhanced survival compared to placebo for all botulinum neurotoxin serotypes and arrested or mitigated the progression of clinical signs of botulism intoxication. These results demonstrated the therapeutic efficacy of BAT product in guinea pigs and provided supporting evidence of effectiveness for licensure of BAT product under FDA 21 CFR Part 601 (Subpart H Animal Rule) as a therapeutic for botulism intoxication to serotypes A, B, C, D, E, F or G in adults and pediatric patients.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Animals
  • Antitoxins / pharmacology*
  • Bioterrorism / prevention & control
  • Botulinum Antitoxin / pharmacology*
  • Botulinum Toxins / antagonists & inhibitors*
  • Botulism / metabolism*
  • Disease Progression
  • Female
  • Guinea Pigs
  • Horses
  • Male
  • Mice
  • Neurotoxins / antagonists & inhibitors*
  • Serogroup

Substances

  • Antitoxins
  • Botulinum Antitoxin
  • Neurotoxins
  • Botulinum Toxins

Grants and funding

This work was funded by the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (DHHS) under contract HHSO100200600017C. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. The funder had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.