If you had a chronic and potentially debilitating condition such as rheumatoid arthritis or Crohn's disease, and swallowing the eggs of a pig parasite could help, would you do it?
The team at Coronado Biosciences Inc is betting you would.
The Burlington, Mass., company is developing what it hopes will be the first in a new class of treatments for autoimmune conditions. Each dose of the drug consists of thousands of microscopic parasite eggs, culled from pig feces, suspended in a tablespoon of saline solution to be swallowed.
In a pig, the eggs would grow into mature whipworms and reproduce, without harming their host. In humans, the same eggs barely survive two weeks. Yet in that short period they appear to modulate a patient's immune system and prevent it from attacking the body's own tissues and organs.
"It has the potential not only to be a drug but to provide insight into the cause of these diseases," said Dr. Joel Weinstock, chief of gastroenterology and hepatology at Tufts-New England Medical Center in Boston and an adviser to Coronado.
The company is preparing to enroll 220 patients with Crohn's disease in a midstage clinical trial. Participants will receive either a dose with 7,500 eggs from a pig whipworm or a placebo once every two weeks for 12 weeks.
Coronado's partner, German drugmaker Dr. Falk Pharma GmbH, is conducting a midstage trial of the drug, known as trichuris suis ova (TSO), in Europe. The two companies plan to share data when filing for marketing approval in 2016 or 2017.
Tiny Coronado, with a market value of nearly $139 million, went public on the Nasdaq stock exchange last December. If the company, which also has an early-stage cancer drug in development, succeeds with TSO, it will compete against multibillion-dollar drugs from Amgen Inc and Abbott Laboratories.
Sales of autoimmune disease drugs are expected to grow in the mid-single-digit percentages through 2016, from $34 billion in 2010, according to market research firm BCC Research.
As many as 700,000 Americans suffer from Crohn's disease, a bowel disorder. An estimated 50 million Americans have rheumatoid arthritis and as many as 7.5 million suffer from psoriasis.
The technology behind Coronado's product was developed by Weinstock and researchers at the University of Iowa, where Weinstock was affiliated before Tufts. It is based on the "hygiene hypothesis," which holds that many developed countries have, in some ways, become too clean for their own good.
Millions of organisms, including viruses, bacteria and worms, enter the body through contact with dirt. Researchers believe many of these organisms are needed to train the body's immune system to recognize and fight disease.
"Microbes have adapted to us, and us to them, and we use them to stimulate our immune system," said Dennis Kasper, a professor of medicine, microbiology and immunobiology at Harvard Medical School, who is not involved with Coronado's product.
Today in many parts of the world these organisms are kept at bay with an array of antibacterial soaps, detergents and sanitizing gels.
Studies have shown that the incidence of autoimmune disease tends to be highest in the developed world, and is highest there among upper-income groups. Weinstock and others hypothesize that the elimination of certain intestinal parasites may have led to the loss in some individuals of a key mechanism for modulating the immune system.
Standard treatments for autoimmune disorders include injectable drugs that block a protein known as tumor necrosis factor. They include Amgen's Enbrel and Abbott's Humira. These depress the immune system and send its army of infection-fighting cells back to their barracks.
They also raise the risk of serious infection, including tuberculosis, and some types of cancer. Coronado's chief executive officer, Bobby Sandage Jr., says that is one reason why patients with serious conditions would choose the company's drug despite its provenance.
"With the pig whipworm, there is no permanent infection, no real possible side effects," he said.