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  [99]Science & technology | The antibiotics crisis

Western firms are becoming interested in a Soviet medicine

“Phage therapy” aims to use viruses to cure bacterial infections

  ^BT4 bacteriophage.^b Coloured transmission electron micrograph (TEM)
  of a ^IT4 bacteriophage^i virus. The swollen structure at top is the
  head, which contains DNA inside a protein coat. Attached to this is the
  tail, consisting of a tube-like sheath and tail fibres (at bottom).
  ^IT4 bacteriophages^i are parasites of ^IEscherichia coli^i, a bacteria
  common in the human gut. The virus attaches itself to the host bacteria
  cell wall by its tail fibres; the sheath then contracts, injecting the
  contents of the head (DNA) into the host. The viral DNA makes the
  bacteria manufacture more copies of the virus. Magnification: x110,000
  at 6x4.5cm size.
  May 3rd 2023 | Tbilisi
  (BUTTON) Share

  It was on the golf course that Barry Rud first noticed something was
  seriously wrong. A trim 60-year-old who played hockey as a young man,
  he found himself unable to take more than a few steps without gasping
  for breath. His doctors said he had caught a strain of Pseudomonas
  aeruginosa, one of the growing number of [100]“superbugs” that have
  evolved resistance to many common [101]antibiotics.

  Mr Rud’s experience illustrates a growing problem—and one possible
  solution to it. Antibiotics are among medicine’s most spectacular
  achievements. A class of “silver bullet” drugs that destroy
  disease-causing bacteria while sparing the patient’s own cells, they
  have defanged all sorts of once-feared illnesses, from cholera to
  syphilis. They have drastically reduced the risks of surgery (patients
  often died from infections caught on the surgeon’s table) and
  chemotherapy, which destroys the patient’s immune system.

  But their magic is waning. Repeated exposure to a lethal threat has led
  bacteria to evolve resistance to many existing antibiotics, blunting
  their effectiveness. At the same time, the pharmaceutical industry has
  lost interest in finding new ones. It has been almost 40 years since a
  new class of antibiotics has been made available to patients. Some
  infections, including gonorrhoea and tuberculosis, are once again
  becoming difficult to treat. One estimate, published in the Lancet in
  2022, reckons antibiotic resistance directly caused 1.2m deaths in
  2019, and was indirectly implicated in 3.8m more.

  With antibiotics unable to cure his illness, Mr Rud took a chance. He
  travelled to the Eliava Institute in Tbilisi, Georgia, one of a handful
  of institutions specialising in the study of bacteriophages. These are
  viruses that infect and kill bacteria. The Eliava Institute uses them
  as living antibiotics, hoping to cure a human’s disease by causing one
  in the bacteria making him sick.

  “Phages” are little known outside the former countries of the Soviet
  Union, which did the most to develop the idea. In Georgia they have
  been part of the local pharmacopoeia for decades. (Indeed, 2023 marks
  the Eliava’s centenary.) Little vials containing stale-tasting liquid
  full of anti-bacterial viruses can be bought at pharmacies across
  Tbilisi. Now, as worries about antibiotic resistance build, Western
  firms are taking a second look.

Set phages to kill

  Despite their name, bacteriophages infect, rather than eat, their prey.
  Owing to the profusion of bacterial life, phages are the most abundant
  biological entities on the planet. Most resemble a cross between a Moon
  lander and spider. An icosahedral head (think of a 20-sided die) holds
  their genome, and is attached to a tail of proteins that culminates in
  a spray of fibres. When the fibres encounter a suitable receptor on a
  bacterial cell wall, they bind the phage to its victim, driving its
  tail through the cell’s membrane and allowing its genome to enter its
  new host.

  One of two possible fates awaits the unfortunate bacterium. “Lysogenic”
  phages weave their own genomes into that of their host, leaving it
  alive with its new cargo of viral DNA. If the phage is “lytic”, though,
  it hijacks its host’s cellular machinery to assemble copies of itself.
  These proliferate until they burst out, killing the bacterium in the
  process. It is the latter sort of phage that is of interest to doctors.

  As living antibiotics, phages have several advantages, at least on
  paper. Since they can make more of themselves, initial dosages can be
  relatively small. Unlike chemical antibiotics, they can evolve as
  readily as their prey, potentially blunting a bacterium’s ability to
  develop resistance. And the myriad differences between human cells and
  bacterial ones means they are unlikely to do any damage to the patient.

  A century ago, phages were the most promising tool in the antibacterial
  arsenal. Felix d’Herelle, a microbiologist at the Pasteur Institute in
  Paris, used them to treat the first patient in 1919, after downing a
  dose himself to ensure they had no harmful effects. One of his
  colleagues was a young Georgian scientist named George Eliava, who
  returned home to found the institute that now bears his name.

  But with the discovery of penicillin, the first antibiotic, in 1928,
  phages fell from favour. Production of penicillin surged during the
  second world war, crowding the phages out. That has left a shortage of
  good-quality trial data on their use in humans. (The first and so far
  only clinical trial on phages in Britain ended in 2009, concluding they
  were both safe and effective against an ear infection). What data exist
  indicate that phages are not harmful to humans. Four reviews of the
  available literature, all published since 2020, suggest very low rates
  of adverse affects (the figure for antibiotics, phage researchers are
  quick to point out, can be as high as 20%).

  How well phages actually do at curing infections, though, is another
  question. Although encouraging anecdotal evidence has been trickling in
  for decades, regulators need big, formal clinical trials. A report
  published last year by the Antibacterial Resistance Leadership Group, a
  gathering of experts, concluded that the lack of data meant phages were
  not ready for clinical use. “We have a lot of catching up to do,” says
  Steffanie Strathdee, a director of the Centre for Innovative Phage
  Applications and Therapeutics at the University of California, San
  Diego.

  That uncertainty has not stopped a wave of medical tourism to the
  Eliava Foundation’s Phage Therapy Centre. It treats more than 500
  foreign patients a year. Most, like Mr Rud, are charged €3,900 ($4,300)
  for two weeks of on-site treatment and months’ worth of bottled phage
  to take home. Patients from more than 80 countries have visited the
  clinic.

  Treatment involves three steps. The first is to figure out exactly
  which bacterium is responsible for the disease. Proper identification
  is crucial, as some phages are so target-specific that they may have
  different effects on two bacteria from within the same species. Second,
  a phage has to be found that can successfully attack the bacterium in
  question. This can sometimes be done simply by looking in existing
  phage libraries, of which the Eliava has one of the world’s largest.

  Sometimes, though, its researchers must go hunting for something
  suitable. The core principle is to look for a phage in the same place
  as one would find the bacteria it infects. In practice this often
  involves a lot of laborious sifting through human sewage and hospital
  waste, as these are reliable sources of resistant bacteria. (So are
  urban rivers such as the Mtkvari, which runs by the Eliava’s grounds.)

  Finally, the phages must be encouraged to grow, and the resulting
  solution purified. Although the number of laboratories that can
  replicate parts of this process is on the rise, Vakho Pavlenishvili,
  the Eliava Foundation’s head of phage production, says it remains the
  only place capable of handling the entire process from bacterial
  analysis through to phage prescription.

  But expertise is spreading. More clinical trials of phage therapy have
  begun around the world in the past three years than in the preceding
  two decades (see chart). In 2022, Technophage, a Portuguese company,
  completed a trial of a phage cocktail designed for patients with
  diabetic foot ulcers. It hopes to begin the next round of trials
  sometime later this year. BiomX, an Israeli firm, is testing a phage
  cocktail of its own on P. aeruginosa, a common cause of
  hospital-acquired infections. Adaptive Phage Therapeutics, an American
  firm, has three trials in the works: one on cystic-fibrosis patients
  with opportunistic infections, one for infections in prosthetic joints,
  and, like Technophage, one on diabetic foot ulcers.

  One problem facing would-be phage therapists is that, as natural
  entities, phages cannot be patented. One solution is to tinker with a
  phage’s genome, since edited genomes are eligible for protection. A
  Danish company called SniprBiome hopes to produce tweaked phages
  capable of tackling E. coli infections. It has completed initial trials
  in humans, and hopes to discuss bigger ones with regulators later this
  year.

  Even if the phages themselves cannot be patented, other things made
  from them can. Dressings or implants coated in phages are one example.
  Adaptive Phage Therapeutics has patented parts of its phage library and
  its high-speed manufacturing process. The firm hopes to be able to go
  from the identification of a bacterium to regulatory approval of a
  phage to kill it within six months. The same process could take 15
  years for a new antibiotic, says Greg Merril, its founder.

  Regulators are adapting, too. In America the Food and Drug
  Administration has allowed companies to accelerate their early-stage
  clinical trials. In 2018 regulators in Belgium adopted new rules known
  as the Magistral pathway, which allow pharmacies to sell phages to
  patients who have a prescription. The researchers who lobbied for the
  new rules hope to see similar changes across the rest of the EU. “I
  find [British regulators] to be incredibly engaged and interested,”
  says Martha Clokie, a researcher at the University of Leicester. She is
  part of a collaboration that hopes to bring high-quality phage
  manufacturing to Britain, and to build up a national phage library to
  go with it.

  And phages could find uses outside medicine, too. They have been used
  to treat rot in cabbages for almost a century. Trials have begun on
  potatoes, corn, citrus fruit and grapevines. Animal farming consumes
  huge quantities of antibiotics, prescribing them to cattle and pigs to
  encourage growth. That makes the industry a big driver of antibiotic
  resistance. ACD Pharma, a Norwegian firm, has spent 15 years
  researching the potential application of phages to fish-farming. It
  launched a product to tackle a single bacterium in salmon in 2018. In
  2022, sales rose 1,000%. The firm is trying to adapt its product to
  tackle other types of bacteria, too.

Make it so

  For now, though, all these remain hopes rather than certainties. There
  are plenty of questions left to answer. Some are big and conceptual.
  Since phages are foreign bodies, for instance, they are likely to spur
  a patient’s immune system to produce antibodies to neutralise them.
  That could be a problem, especially with repeat prescriptions, as a
  body primed to repel a phage is one in which its effectiveness will be
  limited. Whether phages can be tweaked to overcome such defences
  remains to be seen. Others are humdrum but essential: doctors will need
  to work out ideal doses, the best administration mechanisms, and which
  sorts of patients might be best suited to the treatment.

  Not even the most dedicated advocates of phages think they will replace
  antibiotics. But they hope they might serve as a treatment for
  infections for which nothing else works, or as a supplement to
  conventional antibiotics in order to strengthen their effects. For that
  to happen, though, will require building the infrastructure to explore
  the idea properly. For now, the facilities to do that simply do not
  exist. “We can receive a thousand patients,” says Dr Sturua, back at
  the Eliava Institute. “But we can’t receive a million.” ■
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[106]After half a century, there is a commercial market for Moon missions

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