BARDA to fund development of antibiotic for melioidosis
Venatorx Pharmaceuticals announced this week that it has received a contract from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) to develop the combination antibiotic cefipime-taniborbactam for treatment of melioidosis.
Under the terms of the agreement, Venatorx, of Malvern, PA, will receive $318 million to develop the drug, which combines a fourth-generation cephalosporin with a beta-lactamase inhibitor, to treat melioidosis, a respiratory disease caused by the bacterium Burkholderia pseudomallei. The contract includes funding for a completion of a clinical study and options to procure cefipime-taniborbactam for national preparedness efforts.
Venatorx has been developing cefipime-taniborbactam as a treatment option for patients with difficult-to-treat infections caused by multidrug-resistant bacteria, and recently completed a phase 3 clinical trial in patients with complicated urinary tract infections. The company expects to submit a New Drug Application for that indication to the Food and Drug Administration in 2023.
"The contract supports Venatorx's mission to address the devasting impact on patient lives from the growing multidrug-resistant bacterial infections in the US," Christopher J. Burns, PhD, president and CEO of Venatorx, said in a press release. "Venatorx and cefepime-taniborbactam can play an important role in helping to enhance the biodefense preparedness of our country, save lives and protect Americans."
B pseudomallei is most commonly found in soil and water in tropical regions, including South and South East Asia, northern Australia, and parts of Central and South America, Puerto Rico, and the US Virgin Islands. Most melioidosis cases in the United States have been linked to travel to and products imported from these regions. But the US Centers for Disease Control and Prevention (CDC) said in July that environmental sampling indicated the bacterium has been in soil and water in the Gulf Coast region of Mississippi since 2020 and is now considered locally endemic.
Often described as "the great mimicker" because it looks like other conditions, melioidosis symptoms can include fever, localized pain or swelling, cough, chest pain, respiratory distress, weight loss, muscle or joint pain, headache, and seizures. Melioidosis is fatal in anywhere from 10% to 50% of those infected.
Oct 3 Venatorx press release
Jul 27 CDC Health Alert Network advisory
Study: US children exposed to antibiotics frequently at an early age
An observational study of privately insured US preschoolers found a high volume of antibiotic prescribing, particularly in children with chronic medical conditions, researchers reported today in Clinical Infectious Diseases.
To address the evidence gap in pediatric antibiotic prescribing in the United States, and any links with chronic comorbidities, researchers from Harvard T.H. Chan School of Public Health and Harvard Medical School studied medical claims data from a cohort of 124,759 children under the age of 5 with private medical insurance. The primary outcomes were the cumulative number of antibiotics dispensed per child by age 5, and the proportion of children for whom at least one antibiotic was prescribed by age 5. The researchers also identified which chronic medical conditions predicted whether a child would be among the top 20% of antibiotic recipients.
Children in the cohort received a mean of 6.8 antibiotic courses by the age of 5, with 91% of children receiving at least one antibiotic course by 5. Most antibiotic courses (71%) were associated with respiratory tract infections. The presence of an underlying medical condition generally increased the odds that a child would be among the top 20% of antibiotic recipients, with pulmonary/respiratory conditions (odds ratio [OR], 2.64), otologic conditions (OR, 2.62), and immunological conditions (OR, 2.53) associated with the greatest increase in the odds of being in the highest consumption group. Children with at least one of these conditions received a mean of 10.5 antibiotic courses by age 5.
The study authors say the results are broadly consistent with studies that have measured cumulative antibiotic use in children in other high-income countries.
"Reducing rates of respiratory illness, through vaccination or other means, may be an effective way of achieving reductions in early pediatric antibiotic use, especially if these interventions are targeted in children with chronic conditions that predispose them to frequent receipt of antibiotics," they concluded.
Oct 5 Clin Infect Dis abstract