Stewardship / Resistance Scan
Promise of bacteriophage therapy; New reimbursement models for antibiotics.
Paper highlights promise of bacteriophage therapy
A new paper in Open Forum Infectious Diseases lays out some of the lessons learned from cases of antibiotic-resistant infections treated with bacteriophage therapy.
For the paper, researchers with the Center for Innovative Phage Applications and Therapeutics (IPATH) at the University of California, San Diego, reviewed nearly 2 years of consult requests for bacteriophage therapy and examined outcomes from the first 10 cases at the center treated with intravenous (IV) bacteriophage therapy. IPATH was launched in 2018 to expand clinical use of the bacteria-killing viruses against multidrug-resistant infections.
Of the 785 requests from patients and physicians, 82% were for treatment of bacterial infections, primarily those caused by Pseudomonas aeruginosa, Staphylococcus aureus, and Mycobacterium abscessus. Bacteriophage therapy was administered to 17 of 119 patients in whom it was recommended, and the median time from request to administration was 170 days.
Review of the first 10 cases, seven of which had successful outcomes, showed that administration of IV and nebulized bacteriophage therapy appears safe, may be safely administered by outpatients, and can be used to suppress infections. The review also found that bacterial resistance to bacteriophage therapy can develop but can be overcome with new phages, that combining phages and antibiotics can lead to successful outcomes despite the presence of in vitro antibiotic resistance, and that treatment failure can occur despite in vitro phage susceptibility.
“In conclusion, our experience with BT [bacteriophage therapy] for a variety of indications highlights the promise of BT for multiple clinical indications,” the authors of the paper wrote. “Significant work is needed to identify predictors of success and for design of clinical trials that will lead to more widespread use.”
Aug 27 Open Forum Infect Dis abstract
European drug makers call for new reimbursement models for antibiotics
The BEAM (Biotech companies in Europe combating Antimicrobial Resistance) Alliance late last week urged the European Union (EU) and individual member states to adopt new reimbursement models for antibiotics.
In a paper on its website, the alliance, which includes 70 small- and medium-sized European companies involved in antibiotic development, called on the European Commission to create a new pull incentive framework that would help make new antibiotics more commercially viable and to provide guidance to member states on the size of the incentives that would be required.
The group also encouraged member states to champion and adopt a new EU legislative framework that would encourage the development of new antibiotics and to create new reimbursement models similar to those adopted in the United Kingdom and Sweden.
“Because new antibiotics are (appropriately) held in reserve, developers of new medicines have struggled financially or have gone bankrupt,” the alliance said. “The BEAM Alliance and the co-signatories of this paper urge the EU and its member states to urgently act and fix the broken economics around investment into the development and commercialization of antimicrobials.”
In another paper posted on its website last week, the alliance applauded the launch of the AMR Action Fund, a nearly $1 billion effort by pharmaceutical companies to support late-stage antibiotic development announced earlier this summer. But the group noted that the fund “must be matched by a commercial ecosystem that is supportive of innovation in the field, so that the antibacterial drugs developed as a result of this funding can be truly viable from a market as well as scientific and clinical perspective.”
Aug 28 BEAM Alliance paper on new reimbursement models
Aug 27 BEAM Alliance reflection paper on the AMR Action Fund