The California Supreme Court sided with Gilead Sciences in a closely watched case brought by thousands of patients who argued the company was negligent for slow-walking development of an HIV medicine that was safer than another drug it was already selling.

In a 6-1 decision, the court overturned a state appeals court ruling two years ago that Gilead could be held liable, raising alarm in the pharmaceutical industry that drug development decisions could be influenced by the fear of legal liability.

The case began after more than 24,000 people claimed in federal and state court lawsuits that they unnecessarily suffered kidney injury and bone loss from the older drug. They maintained that Gilead cynically managed its product pipeline at the expense of people who should have been treated with a safer medicine.

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Recurrent urinary tract infections (rUTIs) are among the most common bacterial infections worldwide. The difficult-to-treat condition, which affects primarily women, is defined as two urinary tract infections (UTIs) within six months or three UTIs within the past year. They are a leading cause of outpatient antibiotic use, accounting for more than 15% of all prescriptions.

While antibiotics remain the standard treatment, frequent recurrences and rising antibiotic resistance highlight the need for alternative therapeutic approaches. Now, researchers have, for the first time, administered a combined phage therapy (PT) with fecal microbiota transplantation (FMT), to decolonize urinary and intestinal reservoirs of rUTI patients.

The novel treatment approach, combining PT and elective FMT, was administered to three female patients, between May and July 2023, with rUTI that did not respond to antibiotics and commonly used non-antibiotic strategies. All had microbiologically confirmed E. coli in multiple infections.

All three women received PT orally and intravesically (locally applied to the bladder via catheter) for eight days outside of acute episodes. Two of these three patients were elected to receive subsequent FMT. Since the bacteria causing the recurring infections often reside in the gut as well as the urinary tract, the FMT treatment targeted the intestinal reservoirs of E. coli that survive antibiotic treatment of acute infections and can become increasingly resistant.

“While phage therapy acts to remove the pathogen, FMT aims to restore a healthy microbiome, combining both immediate and long-term effects,” Lena Biehl, MD, PhD, group leader at Fraunhofer ITMP, deputy lead of Cologne Microbiota Bank, University Hospital Cologne.

This work is published in Nature Microbiology in the paper, “Combined Phage therapy and fecal microbiota transplantation to treat recurrent urinary tract infection: a case series.”

The treatments were well tolerated and did not result in noticeable side effects. The two patients who received the combination therapy have experienced a long-term reduction of UTIs over the course of two years, while the one patient with PT only has experienced further episodes but with reduced symptoms. For all patients, although E. coli was detected in follow-up samples, quality of life improved significantly, while the need for antibiotic treatment was substantially reduced.

“Three patients are not a sufficiently large sample to establish this new therapy, and control groups were lacking. However, this experience has helped to lay the foundation for a clinical trial in order to test the clinical utility of this treatment approach and make it more widely available and sustainable for patients,” comments Shawna McCallin, MD, at the Balgrist University Hospital in Zurich.

The clinical trial is scheduled to begin in June 2027 at the participating institutions as part of the REPhRAME project, which is funded by the European Commission through the Horizon Europe funding programme.

The post Combined Phage Therapy and FMT Reduces Recurrent UTIs and Antibiotic Use in First Human Case Series appeared first on GEN – Genetic Engineering and Biotechnology News.

Last month, STAT reported that Eli Lilly granted a single 79-year-old patient special access to retatrutide, an unapproved obesity drug that has demonstrated bariatric-surgery levels of weight loss. 

Since then, at least a handful of clinicians have tried to seek the same access for their patients. Two of them haven’t received answers from the drugmaker for weeks; one heard back on Monday, only after STAT reached out to Lilly with questions for this story, that his patient might qualify for access to the drug.

The lack of clarity from Lilly raises new questions about why the company gave extraordinary access to an experimental obesity drug to a single patient. Clinicians are calling for more transparency from Lilly on whether the company plans to expand access, or whether this was a one-time, special circumstance. 

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