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upstart writes:

Regulators have to figure out how to get them on the market:

Ella Balasa was 26 when she realized the routine medical treatments that sustained her were no longer working. The slender lab assistant had lived since childhood with the side effects of cystic fibrosis, an inherited disease that turns mucus in the lungs and other organs into a thick, sticky goo that gives pathogens a place to grow. To keep infections under control, she followed a regimen of swallowing and inhaling antibiotics—but by the beginning of 2019, an antibiotic-resistant bacterium lodged in her lungs was making her sicker than she had ever been.

Balasa's lung function was down to 18 percent. She was feverish and too feeble to lift her arms over her head. Even weeks of intravenous colistin, a brutal last-resort antibiotic, made no dent. With nothing to lose, she asked a lab at Yale University whether she could volunteer to receive the organisms they were researching: viruses that attack bacteria, known as bacteriophages.

[...] And it worked. The viruses penetrated the goo, attacked the bacteria, and killed a portion of them; the rest of the bacteria weakened enough that antibiotics could knock them out. Balasa's body cleared the life-threatening infection faster than ever before.

[...] There's an asterisk to her success: Phages are unapproved drugs, not just in the United States, but in the United Kingdom and Western Europe, too. No company makes them for commercial sale in those countries, and hospitals and pharmacies don't stock them. To administer them, physicians must seek a compassionate-use authorization from a government regulator—in Balasa's case, the US Food and Drug Administration—showing their patients have no other options.

A little more than a century after they were first used to cure an infection, it might finally be phages' time.

[...] To be fair, there are places where this would be old news. Phages pervade the natural world: There are possibly trillions of them distributed through every niche of the environment, each tuned by evolution to kill just one type of bacteria. And there are countries where doctors have been using them for decades. After World War I and a decade before the first recognition of antibiotics, a self-taught microbiologist named Félix d'Hérelle harnessed phages' natural killing ability to cure dysentery in several children in Paris. By the 1930s, he had found a research home in what's now the Republic of Georgia. After Stalinism closed the USSR off from Western Europe and the US, phage research quietly flourished there.

It wasn't until the USSR collapsed in 1991 that phage treatments came to the attention of countries with big research budgets, via atmospheric news accounts of funding-starved researchers jury-rigging equipment in the dark. That was good timing, because it was simultaneously becoming clear that antibiotics were losing their power against rising drug resistance. Globally, it's estimated that 1.27 million people per year die from resistant infections. The World Health Organization calls drug resistance a "silent pandemic" that could kill 10 million people per year by 2050.

[...] In many ways, phages look like the solution to problems that beset antibiotics. They each kill only one type of bacteria, so they are less likely to disrupt microbiomes. They penetrate complex matrices that defeat antibiotics—not just the thick mucus caused by cystic fibrosis, but the thin films of organisms that develop on pacemakers and artificial joints. And they are unthinkably abundant, a refreshing change from an antibiotic pipeline that gets ever more narrow as companies search for novel ways to attack bacteria.

"This is one of the challenges of the phage space right now: There are all these tantalizing little indications that maybe something good can come from this technology," says Robert McBride, cofounder and CEO of Felix Biotechnology, which has been funded by the Cystic Fibrosis Foundation to develop a Pseudomonas phage that was identified at the Yale Center. "And yet we still don't have a rigorous, large, controlled, blinded set of data to support the general case."

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