BAT (botulism antitoxin heptavalent) / Emergent Biosolutions - LARVOL DELTA

BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients (clinicaltrials.gov) - P4 | N=10 | Enrolling by invitation | Sponsor: Emergent BioSolutions | Active, not recruiting ➔ Enrolling by invitation

Enrollment open • Pediatrics

BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients (clinicaltrials.gov) - P4 | N=7 | Active, not recruiting | Sponsor: Emergent BioSolutions | Completed ➔ Active, not recruiting | Trial completion date: Jul 2017 ➔ Jul 2027 | Trial primary completion date: Jul 2017 ➔ Jul 2027

Enrollment closed • Trial completion date • Trial primary completion date • Pediatrics

Exposure-Response Modeling and Simulation to Support Human Dosing of Botulism Antitoxin Heptavalent Product. (PubMed, Clin Pharmacol Ther) - "Furthermore, this BAT product dose is expected to result in a significant protection against clinical signs in human adults for all botulinum neurotoxin serotypes. Our exposure response model indicates that we have sufficient antitoxin levels to give full protection at various theoretical exposure levels and based on neutralization capacity/potency of one dose of BAT product it is expected to exceed the amount of circulating botulinum neurotoxin."

Journal • Pediatrics

Use of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) (BAT) in Clinical Study Subjects and Patients: A 15-Year Systematic Safety Review. (PubMed, Toxins (Basel)) - "For patients properly managed in an intensive care setting, the advantages of BAT product appear to outweigh potential risks in patients due to morbidity and mortality of botulism. AEs of special interest, including bradycardia, hemodynamic instability, hypersensitivity, serum sickness, and febrile reactions in the registry, were specifically solicited."

Adverse events • Clinical • Journal • Review • Cardiovascular • Critical care • Immunology • Pediatrics

Wound Botulism in Black Tar Heroin Injecting Users: A Case Series. (PubMed, J Investig Med High Impact Case Rep) - "In this article, we present 3 cases of wound botulism, in which the patients presented with bulbar weakness and were treated with botulism antitoxin heptavalent. The time to antitoxin administration and its effect on the patients' clinical courses is compared."

Clinical • Journal • Gastrointestinal Disorder • Immunology

Outbreak of foodborne botulism in Alexandria, Egypt: modulating indications for administration of heptavalent botulinum antitoxin. (PubMed, Environ Sci Pollut Res Int) - "In an attempt to allocate the resources, not all patients were given HBAT (botulism antitoxin heptavalent (A, B, C, D, E, F, G) equine immediately...However, eighty-two (87.2%) of patients were completely cured, whereas ten patients (10.6%) were discharged with mild neurological sequels and death occurred only in two cases (2.2%). Sixty cases (63.8%) with suspected foodborne botulism could be managed by supportive treatment only with no need for HBAT, while patients with evident neurological signs received HBAT immediately."

Journal

[VIRTUAL] Wound botulism in black TAR heroin injecting users (WSMRF 2021) - "If there is high clinical suspicion, a prompt administration of botulism antitoxin heptavalent (BAT) should be considered...The history of drug injection and signs of infection especially around the drug injecting sites further increase the suspicion. The timely administration of BAT can significantly lessen the duration and severity of wound botulism."

CNS Disorders • Complement-mediated Rare Disorders • Dermatomyositis • Fatigue • Immunology • Myasthenia Gravis • Myositis • Nasopharyngeal Carcinoma • Oncology • Respiratory Diseases • Solid Tumor

[VIRTUAL] IATROGENIC BOTULISM (CHEST 2020) - "The patient was administered the Botulism Antitoxin Heptavalent antibody (BAT). Patients with compromised respiratory status treated with BOTOX injections for spasticity should be monitored closely."

Cerebral Palsy • CNS Disorders • Complement-mediated Rare Disorders • Dystonia • Immunology • Movement Disorders • Myasthenia Gravis • Otorhinolaryngology • Urinary Incontinence • Urology

"#CPNP2018 KEYNOTE SPOTLIGHT: Michael E. Thase, MD https://t.co/EJTmJivyB0" (@psychpharm)

Biosimilar

Cost savings associated with timely treatment of botulism with botulism antitoxin heptavalent product. (PubMed, PLoS One) - "Substantial economic savings can be achieved with early BAT product treatment. The findings support the recommendation for public health authorities to ensure antitoxin treatment is readily available in sufficient quantities to manage botulism cases, including sporadic outbreaks and potential mass exposure biological attacks."

HEOR • Journal

Therapeutic efficacy of equine botulism heptavalent antitoxin against all seven botulinum neurotoxins in symptomatic guinea pigs. (PubMed, PLoS One) - "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."

Clinical • Journal

Efficacy of equine botulism antitoxin in botulism poisoning in a guinea pig model. (PubMed, PLoS One) - "These studies confirm the efficacy of BAT as a post-exposure prophylactic therapy against all seven known BoNT serotypes."

Clinical • Journal

Safety and Clinical Outcomes of an Equine-Derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. (PubMed, Clin Infect Dis) - "BAT product was well tolerated in patients. Treatment with BAT product ≤2 days of symptom onset was associated with shorter hospital and intensive care unit stays, and shorter duration and need for mechanical ventilation, showing clinical benefit associated with early treatment."

Clinical • Clinical data • Journal