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FDA green lights study of phage-based drug for resistant infections

Possible alternative to conventional antibiotics

FDA

With multidrug resistant (MDR) infections on the rise worldwide, researchers have started looking at using bacteriophages – viruses that only infect bacteria – as an alternative to a dwindling arsenal of conventional antibiotics.

One company working in this area – Adaptive Phage Therapeutics – has just won FDA approval to start human testing of personalised bacteriophage therapeutics for serious MDR infections.

The phase 1/2 trial is the first to be approved by the FDA that will use PhageBank, an ‘expanding phage library’ which aims to overcome the challenge that bacteriophages typically only infect one specific bacterial strain.

All told, around 165 patients with complicated and chronic recurrent urinary tract infections (UTIs) will be enrolled into the study, called BEUTIFL.

Patients will be assigned to treatment with intravenous bacteriophage therapy or intravesical injection into the bladder after a screening process to identify the agents most likely to tackle the infecting bacterial strain.

Arms of the study will also focus on specific bacteria, namely Escherichia coli and Klebsiella pneumoniae which are common UTI pathogens and prone to MDR.

The main objective is to identify ideal bacteriophage regimens based on disease control rates, but the study will of course look at safety as well as UTI recurrence rates over a year.

Underpinning the trial is APT’s technology platform, which allows new phages that are effective against a bacteria to be identified quickly – even if it mutates into a new strain – alongside rapid, automated testing of a patient’s specific bacterial infection to find a matching phage candidate in APT’s PhageBank library.

“Antibiotics…offer static therapies for dynamic pathogens and become obsolete from emerging resistance resulting in market-compressing antibiotic stewardship,” commented Greg Merril, APT’s chief executive and co-founder.

“PhageBank will be the first antimicrobial to increase in spectrum with use – obviating obsolescence and the need for stewardship,” he added.

In March 2016, APT’s approach scored an early victory when it was used as a life-saving experimental rescue therapy for Tom Patterson, a critically ill patient with an MDR strain of the pathogen Acinetobacter baumannii.

He was the first patient in the US to successfully undergo intravenous bacteriophage therapy, and since then several other patients have been treated with APT therapies.

APT is one of a number of biopharma companies trying to harness the bacteria-killing properties of phages to offer an alternative to antibacterial drugs.

Johnson & Johnson recently partnered with Locus Biosciences on a project to engineer phages against pathogens, for example, while Israel’s BiomX and France’s Pherecydes Pharma are also working on phage cocktails for resistant infections.

Ferring Pharma and Institut Pasteur are also exploring phages to tackle bacteria associated with inflammatory bowel disease.

Article by
Phil Taylor

13th March 2020

From: Regulatory

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