Silicon Valley billionaires are pouring millions of dollars into startups who are struggling to create a revolutionary pill from a variety of ailments right down to cancer and Parkinson's disease. The probable basis for a new drug that could turn the pharmaceutical market, the researchers believe the bacteria that live in the human intestines.
The patient experienced severe abdominal pain and was suffering from constant diarrhea. For eighteen months he underwent seven courses of antibiotics, but he just got worse. The young man, who asked not to be named, was not even 30 years before he had health problems. But after gall bladder removal in 2012 he contracted a disease caused by the bacterium Clostridium difficile, which ever since has regularly made itself felt. Bacterium very often strikes those recently treated with antibiotics for other ailments. This treatment negates the effectiveness of what is scientifically called the intestinal flora, the trillions of cells in the body simply no longer cope with its task. "The disease affected not only the health of my gut — says man. — I had a perpetual lack of energy, and the world I saw in the fog. Could not even concentrate on anything".
He is in despair and was looking for possible treatment methods and one day I read an article about fecal transplantation of microbiota, which can fight the infection. But his gastroenterologist refused to carry out the procedure, and he had to take matters into their own hands. The man asked a roommate to share a sample of his chair, bought at a pharmacy kit for the enema, whipped the mixture into a blender, strained it through a coffee filter and was injected into the rectum. Miraculously, the young man was fully recovered in just a few days.
It was the introduction to a story about the most promising new areas of medicine: study of excrement. Studying the last 15 years that literally comes out of patients, an increasing number of researchers are trying to understand how important the health of the intestinal microflora. A new vision can give to the world revolutionary methods of treatment of various diseases — from the obvious like ailments of the digestive system and food allergies to the most unexpected type of cancer and autism. On the basis of the microbiota of the already created drug for the prevention of childhood asthma.
"The diversity of microflora of the digestive system the scientific community has begun to understand only in the last 15 years. It's like a rain forest in the framework of the human body. Genes of bacteria, there is a hundred times more than humans," says Finch Therapeutics founder mark Smith.
Simply put, the idea is the use of intestinal bacteria as a drug. Over the past five years, the impact of the intestinal microbiota has become the subject of more than 50 000 scientific papers. Different types of bacteria to stimulate or, on the contrary, inhibit the reaction of the immune system, and fight other pathogens. With the increasing popularity of advanced studies significantly increases the chance that soon there will be many new therapies and illnesses will be less painful. As pioneers in this field can make good money on these discoveries.
Transplanted cells of the intestinal microflora from mice with normal obese individuals, scientists, for example, recorded in recipients increase body mass. Another study showed that melanoma most effective immunotherapy amenable to those who have the most diverse microflora. In addition, the researchers determined that the mice that have entered the community of marathon runners, too, can travel long distances than ever before. Only one medication from obesity can enrich creators by $20 billion.
Now the most promising treatment is the transplantation of intestinal flora to fight the bacterium Clostridium difficile, which is annually infected half a million Americans, including 15 000 deaths. In 2013, the Medical journal of New England published an article that stirred up the scientific community and provoked a sharp increase in investment in the development of drugs for the treatment of the intestinal microbiota. In the course of the study in a random sample among patients with Clostridium difficile, which introduced a fecal transplant cured 94%. For comparison it should be noted that if it is, for example, about the cancer, the management of quality control food and drugs administration (FDA) of the United States approves the use and production of medicines with the effectiveness of the treatment is only 10%.
"I think no other branch of medicine can not be called as promising as studies of the microbiota of the digestive tract," says the head of the company Vedanta Biosciences Bernat Olle.
In studies of the intestinal microbiota invested billions of dollars. Gbola of ADR, a doctor and a partner specializing in health care investment Bank Chardan from new York, believes that the total investment in this area in 2014 exceeded $5 billion, These billionaires, like bill gates, the founder of Salesforce Marc Benioff and venture capital investor from Silicon valley, Vinod Khosla, are funding startups that are developing products based on the intestinal microflora. In addition, gates, Benioff and mark Zuckerberg have invested in research of the microbiota, maintained in Stanford University, Washington University in St. Louis and the University of California, San Francisco.
Between researchers and start-UPS is a real race — who was the first to develop the drug from the intestinal bacteria, which would approve the regulator? But it is still relatively young and not backed up properly the number of clinical trials. Mark Breidenbach from new York investment Bank Oppenheimer said that the investor interest is reduced, and the reason was "the lack of consensus about what is actually capable of intestinal microflora".
We offer for sale of Chardan much more optimistic: "Science does not stand still. When any medication has finally passed certification, biotech startups in a moment will cost hundreds of millions and billions of dollars."
One of the most promising startups that are developing drugs on the basis of the intestinal microbiota, today is Finch Therapeutics of Somerville, Massachusetts. When the company's founder Mark Smith with requests for help addressed a patient suffering from Clostridium difficile, the researcher was a simple graduate student microbiologist at the Massachusetts Institute of technology (MIT). "I had to tell him that I'm a microbiologist, not a doctor," recalls 33-year-old Smith.
The problem of the patient prompted Smith to establish OpenBiome, analogous to a blood Bank for human feces. Non-profit Foundation was founded in 2013 when Smith has led research activities in the University. The organization is based in neighboring Cambridge and became the world's first Fund of this kind. Since the founding of the stool samples was placed in 1200 hospitals and clinics for more than 53,000 procedures.
Realizing the demand for such techniques, in 2016, Smith has established a commercial firm Finch Therapeutics, naming it in honor of the bird family finches, discovered by Charles Darwin on the Galapagos Islands (from the English. finch "Finch" — approx. ed.) to develop a drug to combat Clostridium difficile and to its production the green light from the FDA. Currently, the majority of doctors take fecal transplantation, through colonoscopy, the price of which can reach up to $5000. Such a procedure is not approved by the regulator and is usually not covered by insurance companies.
Together with its 80 employees Smith occupies two floors in the industrial Park, which previously housed administrative offices and warehouse facilities of the Harvard art Museum. The businessman remembered the tall, slender physique and piercing blue eyes. Often it is necessary to listen to the inevitable jokes that he makes business and human feces. On Halloween, Smith put in office suit Emoji-poop. "I was a stormtrooper excrement" — he describes. Copiers in the office of Finch Therapeutics given names such as "potty" and "Magic Smolny the bus."
Thus, the scientist managed to raise an impressive capital. Venture capital funds invested in start-up $130 million Finch Therapeutics was able to partner with Takeda, pharmaceutical giant from Tokyo. Team Smith is developing a cure for ulcerative colitis and Crohn's disease, which worldwide affects 10 million people. In addition, Finch Therapeutics is working on a drug against autism.
Scientists usually start with data collected from experiments on mice. But Finch Therapeutics takes a different approach and starts right away with people. The company's researchers do not work with rodents and analyze the stool of patients who recovered after fecal transplantation. “We are studying what exactly led to the cure, and we are trying to determine how to make the medicine using the reverse method. This is called reverse translation, ”Smith explains.
As part of the work on one of these drugs against the disease, the causative agent of which is the bacterium Clostridium difficile, the company’s researchers extract the “full spectrum” of bacteria from stool samples from the patients healed, dry-freeze them and develop the equivalent in the form of a regular tablet. The laboratory also deals with simpler drugs, which include five to ten key bacteria. By the end of the second quarter of 2020, the Smith team hopes to complete the second phase of research, during which the effectiveness of a full-fledged capsule against Clostridium difficile will be evaluated.
“Even if only the few treatments that scientists are working on today bring the desired effect, it will have a huge impact on the public health sector,” Smith emphasizes.
The Money Of Bill Gates
Another MIT graduate, a 40-year-old Bernat Olle, the head of the company Vedanta Biosciences, founded nine years ago. Manufacturer drugs on the basis of the intestinal microbiota based in Cambridge, Massachusetts and has funding from investors in the amount of $112 million, including $10 million from the bill and Melinda gates Foundation. Funds from a married couple go on a preclinical study to develop a drug based on the intestinal microflora to combat the problem of malnutrition of children in developing countries. Wasting and stunting affects almost 200 million children under 5 years each year, resulting in 1.5 million deaths. "Children suffering from malnutrition, with difficulty gaining weight, even if getting a sufficient amount of nutrients. According to a recent study, in the case of abnormal development of the intestinal microflora. With properly selected strains of microbiota that imbalance can be corrected," says Olle.
Vedanta Biosciences has partnered with two major pharmaceutical companies, including Corporation Bristol-Myers Squibb. Together, they are developing drugs to increase the effectiveness of immunotherapy in the treatment of melanoma and cancer of the stomach and colon and rectum. As Finch Therapeutics, the team Olle engaged in the development of medicines against recurrent infection with Clostridium difficile.
Inside the labyrinth of labs and warehouses Vedanta Biosciences is a huge freezer that stores feces 275 donors from four continents, including even samples of natives of one of the tribes of Papua New Guinea. The researchers isolated bacteria, and then testing each sample, hoping to determine what strain will work the most effective medicine.
DNA as medicine: cell and gene therapy are changing the pharmaceutical industry
Olle, a man of strong build with short hair and a light gray, goes to work by bike. He moved to the United States from Catalonia in 2002 to study chemical engineering at the Massachusetts Institute of technology. In his work, he focuses on the emerging science about how to use living microorganisms like bacteria for the manufacture of medicines. In 2007, after receiving his doctorate at MIT, and a masters of business administration, School of management Sloan, the researcher began working in a Boston biotech company PureTech Health.
In 2010, the employer has supported him and five other scientists, including Kenya Honda of the medical school at Keio University in Tokyo, in the creation of start-up Vedanta Biosciences. Honda has published breakthrough research work about the relationship of gut bacteria and regulatory T-lymphocytes that prevent inflammatory diseases. "It's kind of UN peacekeepers in the digestive system. In operation Honda said cell, encoded in human DNA, the bacteria affect the internal organs," explains Olle.
"This work has forced me to reconsider my view of the human species. We are more than the product of the genome of Homo sapiens," he adds.
$15 million on sets for home use
Any gold rush attracts charlatans and impostors. In order to market their own kits for stool samples loud the word "microbiome" as a marketing ploy used by almost a dozen startups. Some offer kits with the help of which customers can send their samples to the lab, ostensibly to reveal important medical information about their health and obtain advice about diet. And all this — despite the clear consensus among scientists that to make any effective recommendations about diet, based on the results of the study of human feces is not yet possible. To avoid strict oversight from the regulator, the sellers of these kits have become very cautious and do not give clear guarantees concerning the ability to diagnose or treat specific diseases.
Four years ago, former billionaire and founder of the Internet company InfoSpace Naveen Jain has launched a startup Viome, with an office in Bellevue, Washington. Through the Internet the company sells the "smart test of the digestive system". According to the analysis of a tiny sample of stool the company sends the client a 60-page report with personalized dietary recommendations "aimed at establishing the balance of the intestinal microflora". Among these recommendations may be increasing the so-called Superfoods type alfalfa sprouts or anchovies or rejection of green beans or Kombucha. Jain claims that last year his company sold more than 100,000 sets, and has earned over $15 million.