OM002
OM002 is a synthetic biology-produced human milk oligosaccharide (HMO) 2’-fucosyllactose, or 2’FL. HMOs are the most abundant non-caloric solid component of human milk, of which over 200 distinct HMOs have been identified to date. The single most abundant HMO is 2’FL, which constitutes nearly 30% of the total HMO proportion in human milk.
2’FL has been shown to have direct effects on the microbiome composition, direct anti-inflammatory effects as well as supporting intestinal epithelial health and epithelial barrier integrity. In terms of the effect on the microbiome, 2’FL has a trifold effect, namely prebiotic effects leading to the selective proliferation of beneficial bacteria, inhibition of pathogenic, or disease-causing bacteria, and finally, increase short-chain fatty acid production which is important to maintain the health of the colon cell lining. This suggests that 2’FL has the potential to treat the underlying causes for conditions such as IBS, rather than treating just the major symptoms as in the currently approved therapy.
2’FL has demonstrated ability to:
- Modulate inflammation in preclinical and clinical studies
• Reduce intestinal inflammation and show benefit in multiple colitis mode
• Prevent intestinal inflammation caused by harmful bacteria
• Protect the intestinal lining against damage from cancer drug
• Reduce allergic response to food allergens in mice - Improve gut barrier function in preclinical studies
• Promote the production of beneficial bacteria and increase the production of proteins that help maintain the gut barrier
• Reduce the leakiness of the intestinal epithelial barrier
The prevalence of IBS is approximately 5% of the United States population. IBS is a chronic functional gastrointestinal disorder characterized by abdominal pain and discomfort associated with altered bowel habits. Individuals living with IBS often experience additional symptoms such as bloating, sensation of incomplete evacuation, and straining. The symptoms of IBS not only adversely affect a person’s health-related quality of life, or QOL, but also place a significant financial burden on society because of reduced work productivity and a significant increase (over approximately 50%) in the use of health-related resources. IBS comprises three distinct subtypes, which are categorized based on predominant bowel symptoms (i.e., constipation, diarrhea, or mixed).
IBD consists of 2 major subtypes, Crohn’s disease (CD) and ulcerative colitis. IBD is a result of complex interactions between genetic factors, disrupted immune regulation, the environment, and the gut microbiota, with the end result being chronic inflammation of the digestive tract. CD is characterized by inflammation throughout the entire thickness of the bowel wall. Twenty to 30% of patients will require surgery within 10 years from diagnosis. This is required when the disease is uncontrolled and inflammation or the resulting scarring or fibrosis causes an obstruction of the intestine, most commonly in the distal ileum. Post-operative recurrence of CD is common, and endoscopic recurrence occurs in 70–90% of patients within 1 year of surgery and histologic recurrence can be seen as early as 1 week after surgery.
ASD is a developmental disability that can cause significant social, communication and behavioral challenges. In 2020, the U.S. Centers for Disease Control and Prevention reported that approximately 1 in 54 children in the United States is diagnosed with a form of ASD. People with ASD may communicate, interact, behave, and learn in ways that are different from most other people. The learning, thinking, and problem-solving abilities of people with ASD can range from gifted to severely challenged. Some people with ASD need a lot of help in their daily lives; others need less. ASD can sometimes be detected at 18 months or younger. By age two, a diagnosis by an experienced professional can be considered very reliable. However, many children do not receive a final diagnosis until much older.
OM001
OM001 (3’sialyllactose, or 3’SL) is an acid type HMO and represents a form of HMO bound to sialic acid, or sialylated HMO, and similar to 2’FL is also found naturally in human milk in significant quantities. In human milk, approximately 73% of sialic acid, or SA, is bound to HMOs and 3% is present in free form.
The immunomodulatory effects of HMOs in early life have been of interest to researchers for decades. HMOs can bind to cell surface receptors expressed on epithelial cells and cells of the immune system and thus modulate neonatal immunity in the infant’s gut, and possibly also sites throughout the body. In recent years, 3’SL has been identified as the primary, directly anti-inflammatory HMO in preclinical studies.
In preclinical models, 3’SL has demonstrated ability to:
- Modulate the GBA and certain inflammatory diseases and microbiome indicating importance in normal brain development, learning and memory
- Reduce inflammation and promote healing in animal models of arthritis
- Inhibit or reduce the inflammation in an animal model of atopic dermatitis
oJIA is the most common subtype of juvenile idiopathic arthritis, or JIA, among people of European descent, making up about 40-50% of children with JIA from independent, third party published cohorts of patients as of August 2021. Polyarticular JIA, or pJIA, is the second most common subtype of JIA where the primary differentiation from oJIA is the number of joints affected within first six months of onset. For oJIA, the number of joints affected is four or less, whereas in polyarticular JIA, which is typically more severe than oJIA, the affected individuals present with five or more affected joints.
AD is the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States as of December 2021. Like other immune mediated conditions, the prevalence of childhood AD has steadily increased from 8% to ~12% in decades to 2017. It is a chronic condition that can come and go for years or throughout life and can overlap with other types of eczema. Atopic dermatitis typically begins in childhood, usually in the first six months of a baby’s life. Even though it’s a common form of eczema, it’s also severe and long-lasting.
ASD is a developmental disability that can cause significant social, communication and behavioral challenges. In 2020, the U.S. Centers for Disease Control and Prevention reported that approximately 1 in 54 children in the United States is diagnosed with a form of ASD. People with ASD may communicate, interact, behave, and learn in ways that are different from most other people. The learning, thinking, and problem-solving abilities of people with ASD can range from gifted to severely challenged. Some people with ASD need a lot of help in their daily lives; others need less. ASD can sometimes be detected at 18 months or younger. By age two, a diagnosis by an experienced professional can be considered very reliable. However, many children do not receive a final diagnosis until much older.
OM003
OM003 (6’-sialyllactose, or 6’SL) is another HMO with a sialyllactose backbone and as such shares similar characteristics with 3’SL. Like 3’SL, it is found naturally in human milk, but in greater quantities. While the effects of 2’FL is largely through interactions at and adjacent to the intestinal epithelium, sialyllatose such as 6’SL and 3’SL may cross the blood brain barrier and have direct action in the central nervous system.
In preclinical models, 6’SL has demonstrated ability to:
- Ameliorate the stress response without affecting the composition of the gut microbiota, suggesting it has a direct effect on the neuronal cells
- Combat visceral pain arising from the GI tract, as well as a potential to treat some immune-mediated inflammatory disorders of the GI tract
ASD is a developmental disability that can cause significant social, communication and behavioral challenges. In 2020, the U.S. Centers for Disease Control and Prevention reported that approximately 1 in 54 children in the United States is diagnosed with a form of ASD. People with ASD may communicate, interact, behave, and learn in ways that are different from most other people. The learning, thinking, and problem-solving abilities of people with ASD can range from gifted to severely challenged. Some people with ASD need a lot of help in their daily lives; others need less. ASD can sometimes be detected at 18 months or younger. By age two, a diagnosis by an experienced professional can be considered very reliable. However, many children do not receive a final diagnosis until much older.
Visceral pain occurs when pain receptors in the pelvis, abdomen, chest, or intestines are activated. It is often vague, generally poorly localized, and characterized by hypersensitivity to a stimulus such as organ distension. It often feels like a deep squeeze, pressure, or aching. Consistent with disorders of the GBA, it has been suggested that in concert with chronic visceral pain, there is high comorbidity with stress-related psychiatric disorders including anxiety and depression. Evidence suggests that long-term stress facilitates pain perception and sensitizes pain pathways, leading to a feed-forward cycle promoting chronic visceral pain disorders such as IBS.
