By GREGORY ZELLER // Researchers battling the insidious clostridium difficile infection are making progress on several new fronts, including a novel “poop pill” developed by Symbiotic Health, a spinoff from North Shore-LIJ’s Feinstein Institute.
C. Diff, as it is known, is the most prevalent hospital-acquired infection in the United States and “an immediate public health threat,” according to the Centers for Disease Control. The infection attacks the gastrointestinal tract when broad-spectrum antibiotics fight off infections but in the process kill good bacteria. That weakens a patient’s microbiome, a community of trillions of internal microbes shielding us from dangerous infections like C. diff.
The best current remedies are ineffective for more than 20 percent of all C. diff patients, leading to cases of chronic diarrhea that last months or even years. The infection kills 14,000 Americans annually.
Complicating matters for C. diff patients and healthcare providers are new federal rules limiting reimbursements for patients suffering hospital-acquired infections.
But medical science may finally be taking the upper hand.
At Scripps Mercy Hospital in San Diego, Calif., a fecal microbiota transplant cured a C. diff infection in a 66-year-old man, eliminating populations of multi-drug-resistant organisms in his gastrointestinal tract, according to the Journal of Clinical Microbiology. And the Journal of the American Medical Association reported this week on a promising study led by doctors from Loyola University Chicago’s Stritch School of Medicine. In that test, patients drank an elixir containing nontoxic C. diff spores, with promising results.
Such victories don’t worry Symbiotic Health, now working out of Harlem Biospace, an uptown wet-lab facility located just a subway ride away from numerous NYC universities and research institutions.
Although Symbiotic Health has put all of its eggs in the C. diff basket, its approach – the so-called “poop pill” – is complementary, not contradictory, to the work being done in San Diego and elsewhere, according to Symbiotic founder and CEO Gerard Honig, who cites an “apples and oranges situation.”
For instance, where the Stritch study was “looking to see if their treatment can prevent future relapses, they didn’t look at a specific treatment-resistant population, which is what we did,” Honig noted.
And while both approaches use living bacteria as medicine, there is, of course, the biggest difference of all: The Stritch study involved patients drinking as many as 10 million C. diff spores over a seven-day treatment; Symbiotic Health delivers its payload in a capsule containing processed fecal matter harvested from healthy people.
There’s no denying the gross-out factor, though it could be worse: Previously, processed fecal matter was transplanted exclusively via enemas and nasal tubes. And patients suffering from diarrhea so severe it might kill them are unlikely to complain about the results. And they’ve been good. Symbiotic Health researchers boast a 90 percent cure rate, according to Honig.
Still, the immunologist stressed his company isn’t in competition with other researchers looking to wipe out the GI menace – including the California doctors who performed that revolutionary fecal microbiota transplant, which kept the patient C. diff-free for years, even during an extended stay in intensive care, fertile ground for many hospital-acquired infections.
There is, in fact, “symbiosis” among the different approaches, according to Honig, as well as a common goal of understanding “how diverse bacteria can affect different aspects of human health, and combining them as needed.”
To reach that goal, Symbiotic Health – cofounded by Dr. Bruce Hirsch, who trained in geriatrics and infectious disease at North Shore University Hospital and is an assistant professor of infectious diseases in the North Shore-LIJ Department of Medicine – has been developing methods of growing its own healthy bacteria, as opposed to harvesting fecal matter from donors.
For now, the company plans to remain at Harlem Bioscience, though considering Hirsch’s North Shore-LIJ connections and the biotech momentum generated by the Feinstein Institute, Cold Spring Harbor Laboratory and other Long Island institutions, an eventual move east isn’t out of the question.
“We’ve been very fortunate to work at Harlem Bioscience as we grow our team and transition to more clinically oriented activities,” Honig said. “But we’re definitely looking to expand and we’ll consider a variety of options, including Long Island. Basically, we’ll look for the best space we can find, at the best price, close to public transportation and academic centers.”
Where Symbiotic Health does its thing is less important, he added, than making sure its researchers – and others working around the country – keep their eye on the prize: flushing C. diff for good.
“The gastrointestinal system contains an incredible array of bacteria,” Honig said. “Our goal now is to understand how this diversity can effect different clinical outcomes. The long-term goal is to mix and match the bacteria and nail this disease.”