Editor's note: This article was published on January 16, 2024 in Life Sciences Industry Pharm**oice and was written by Kelly Bilodeau. Compiler Cao Zhi, the content is for reference.
After the FDA approved two microbiome-based programs, there was growing interest in the field.As early as around the 4th century AD, Chinese had used acupuncture to regulate the human microbiome (microbiota) and trillions of organisms in and on the human body (here or referring to modern medicine at home and abroad has been widely recognized: Chinese acupuncture can regulate the health of the human body by affecting "organisms", including intestinal microbes). Chinese used an obnoxious but effective feces-based soup-like mixture to ** severe food poisoning (here or refers to the record of "Huanglong Soup" in the book "Behind the Elbow" written by Ge Hong, a famous doctor in the Eastern Jin Dynasty, ** food poisoning and severe diarrhea, the so-called Huanglong soup is "grinding fecal juice, drinking to one or two liters, called Huanglong Soup......).Translator's note). In other eras and regions, there have been records of doctors using similar diseases such as dysentery and colitis.
A growing body body of microbes plays a key role in rebalancing the body's microbial community, which plays a key role in food metabolism and drug response, immune function, and brain health. The gut, in particular, is filled with microorganisms that the mother introduced into us during pregnancy, which is later influenced and altered by factors such as the environment, medications, and diet.
Now, approaches to these complex biomes (discovery, cultivation, application) are gaining more attention in the pharmaceutical field.
The human body contains more foreign microorganisms than human cells, and each living group in the body is unique to others. Some people have healthier (active in the body) groups than others. Disease occurs when the balance of these (in vivo) organisms is disrupted (called dysbiosis).
In November 2022, the FDA approved the first microbiome-based drug, Ferring Pharmaceuticals' Rebyota (fecal microbiome-contained). The second is the VOWST drug (containing fecal microbiome) developed by Seres Therapeutics in collaboration with Nestlé Health Sciences, a medical nutrition company owned by Nestlé with about 3,000 employees worldwide, which was approved in April last year (2023). Both are Clostridium difficile (C. difficile).diff), about 500,000 people suffer from the disease each year, and about 30,000 of them die. These market access approvals could usher in what IQVIA calls a "new era of microbiome-based medicine."
While indications for gut disease remain a priority, researchers are also actively exploring microbiome-based approaches to multiple sclerosis, inflammatory bowel disease, cancer, mental health disorders, autism, Alzheimer's disease, substance use disorders, and more. By 2025, the market size in this field may reach 4$3.4 billion.
Effects of emerging drugs
Like many of its early predecessors in the field (here or referring to China), (the previously mentioned drug) Rebyota is based on donor "fecal derivatives" that modulate the biological composition in the patient's gut, but (the previously mentioned drug) Vowst takes a different (administration) strategy by isolating the spores from donated human feces and placing them in an oral capsule, which the patient can take at home after a course of antibiotics ** to prevent (Clostridium difficile)**
Moreno Perugini, President of Global Active, Medi-Nutrition, and Global Medicines**, Nestlé Health Sciences, noted: "Previously, the options for Clostridium difficile were limited, with mostly** requiring patients to take antibiotics on an ongoing basis, and in some cases, patients could also ingest fecal microbiota through the rectum to refill the gut microbiota (to achieve gut microbiota rebalancing), but these were not approved by the FDA. It is usually in a research state, and only some medical institutions offer such services".
In clinical studies, patients who took four VOWST capsules daily avoided Clostridium difficile reinfection after eight weeks, compared to only 60% of patients who took a placebo. After six months, 79% of people in the ** group still had no reinfection, compared to more than 50% in the placebo group.
"Because it was designed with the complex interaction between the individual (patient) and the gut microbiome as a breakthrough point, microbiomes like VOWST have the potential to change the way we do some diseases, by targeting the gut microbiota to have a positive impact on metabolic and immune activity and, ultimately, improve the health of patients," noted Moreno Perugi.
While VOWST is currently only approved for the prevention of Clostridium difficile, its range of applications may expand exponentially in the future.
Moreno Perugini further noted: "In the future, we will continue to evaluate the possibility of expanding the scope of utility, either to new indications or to patients with different types of Clostridium difficile. Alterations in the gut microbiome have been implicated in a variety of gastrointestinal and non-gastrointestinal diseases. Currently, the team is exploring the potential of VOWST in more diseases**."
Now, researchers have extended the scope of application to colitis and diarrhea caused by non-Clostridium difficile.
"Based on our extensive expertise in gastrointestinal and nutrition, Nestlé has a strong interest in the gastrointestinal sector and we are currently working to expand our presence in this ** area," Perugini noted.
Pharmaceutical giants are paying more attention to this area
IQVIA claims that other companies such as Johnson & Johnson Innovative Medicine, Takeda and Pfizer have also made tentative forays into the microbiome** market. Because the field is new and risky, large companies sometimes forgo (outright) acquisitions in favor of research in order to have enough time to observe and assess their potential for success.
According to the Microbiome** Innovation Group, an independent consortium of companies consisting of member companies that "have at least one group of microbiome** or microbial-based products gaining market access". The consortium's efforts will focus on: driving the simplification of the microbiome** regulatory process; There are currently more than 220 microbiome technology companies and 700 active projects in the field, according to the sector. Intestinal diseases are still the main direction of product research and development in this field, among which the more representative companies are as follows.
Vedanta Biosciences' ** drugs for Clostridium difficile, inflammatory bowel disease and food allergies have been basically successfully developed; There is also a drug for gram-negative bacterial infections that has also entered the clinical stage of research.
Luca Biologics, a biotechnology spin-off from Seed Health, a microbial technology company dedicated to "accelerating breakthrough science into living organisms," is developing microbiome approaches to common women's health problems, including urinary tract infections (UTIs), bacterial vaginosis, a common infection, and ( inflammation caused by premature birth. The company expects to initiate a Phase 1b clinical trial of the urinary tract infection (UTI) microbiome** product sometime this year (2024).
In addition, Seed Health has partnered with Axial Therapeutics to develop microbiome drugs to ** mental health disorders, including anxiety and depression. Axial focuses on irritability-related mental health issues related to autism, Parkinson's disease, cancer, and non-alcoholic steatohepatitis (NASH).
Maat Pharma is developing the best drugs for diseases such as amyotrophic lateral sclerosis and tumors. Amyotrophic lateral sclerosis is characterized by many changes in microorganisms (in the patient's body); Similarly, the microbiome can influence a patient's response to "checkpoint inhibitor cancer drugs." Therefore, his research direction is to try to improve the effect of related diseases by changing the microbiome.
While much of the research is still in its early stages, the R&D impetus generated by market demand will help pharmaceutical companies better understand the interactions between trillions of microbes from 1,000 different species and the mechanisms by which they interact with disease, based on which to improve people's health.