BARDA to fund development of antibiotics for resistant gram-negatives
San Diego-based biopharmaceutical company Qpex Biopharma today announced it will receive a second round of funding from the Biomedical Advanced Research and Development Authority (BARDA) to develop a portfolio of antibiotics targeting antibiotic-resistant gram-negative bacteria.
Under the Other Transaction Authority (OTA) agreement with BARDA, Qpex will receive $20 million to advance three products into clinical studies: ORAvanceTM, an orally administered beta-lactamase inhibitor (BLI)-based product for treating infections caused by extended-spectrum beta-lactamase (ESBL)- and carbapenemase-producing Enterobacteriaceae; OMNIvanceTM, an intravenous (IV) BLI-based product; and QPX9003, a next-generation IV-administered polymyxin designed to address highly-resistant Pseudomonas and Acinetobacter infections.
The $20 million option is the second award under the OTA agreement, which provides for up to $132 million in funding.
"We are grateful for our successful and longstanding partnership with BARDA, whose commitment to address the global and growing threat of antimicrobial resistance has been unparalleled," Qpex Biopharma President and CEO Michael Dudley, PharmD, said in a company press release. "Our team has made rapid progress since forming the company just over a year ago, and the continued support from BARDA puts us in a strong position as we transition to a clinical-stage company."
Dec 16 Qpex Biopharma press release
WHO announces updates to drug-resistant TB treatment
The World Health Organization (WHO) last week issued a rapid communication outlining updated treatment recommendations for patients with drug-resistant tuberculosis (TB), based on evidence reviewed in a November meeting of its Guideline Development Group (GDG).
The main change suggested by the GDG is the introduction of a shorter, all-oral, bedaquiline-containing drug regimen for patients with multidrug-resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) that would replace shorter regimens with injectables. The recommendation is based on analysis of data from a South African TB program that showed that replacing the injectable with bedaquiline resulted in significantly better treatment success and a considerable reduction in loss-to-follow up in MDR/RR-TB patients who had no previous exposure to second-line drugs, confirmed fluoroquinolone-susceptibility, and no extensive disease or severe extrapulmonary TB.
The group also recommended that in certain patients with extensively drug-resistant TB (XDR-TB), the novel 6- to 9-month bedaquiline, pretomanid, and linezolid (BPaL) regimen may be used under operational research conditions as an alternative to the standard, 18-to-24 month regimen. That recommendation is based on results from the phase 3 Nix-TB trial, in which the BPaL regimen showed high treatment success in 108 South African XDR-TB patients. But the WHO says that the regimen may not considered for programmatic use worldwide until additional safety and efficacy evidence has been generated.
The communication was released to inform national TB programs in advance of the WHO's updated guidelines on drug-resistant TB treatment, which are expected to be published in 2020.
Dec 11 WHO rapid communication
FDA clears disposable duodenoscope
The US Food and Drug Administration (FDA) recently announced that it has cleared the first fully disposable duodenoscope, which is designed to reduce the risk of infection due to difficulties sterilizing the devices.
Duodenoscopes are threaded through a patient's mouth into the top of the small intestine and are used to visualize the upper gastrointestinal tract, and they provide a less invasive way to treat some problems, such as removing pancreatic and biliary duct blockages. However, the devices have many small parts, making them difficult to clean. Some models have been linked to a number of outbreaks involving multidrug-resistant bacteria in US and European hospitals.
The disposable model, called the EXALT Model D single-use duodenoscope, is made by Boston Scientific Corp. In a Dec 13 statement, the company said the device is made for use in endoscopic retrograde cholangiopancreatography procedures (ERCP), and the FDA had granted it breakthrough device designation. Each year, more than 1.5 million ERCPs are performed in the world, according to the company, which added that it plans to start selling the device on a limited basis during the first quarter of 2020.
Jeff Shuren, MD, JD, who directs the FDA Center for Devices and Radiological Health, said in the FDA statement, "The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the U.S. each year."
The new approval comes about a month after the FDA approved a new type of duodenoscope with fewer parts needing disinfection.
Dec 13 FDA statement
Dec 13 Boston Scientific press release
Nov 18 CIDRAP News scan "FDA clears duodenoscope with fewer parts needing disinfection"