OXYGEN
LPOXY Therapeutics is developing a convenient, orally-administered, metered-dose intestinal oxygen delivery therapeutic.
Our aim is to use the healing power of oxygen to protect people from antibiotic-induced C. difficile colitis superinfections and help those suffering from inflammatory bowel diseases.
LPOXY Pipeline Indications
Antibiotic-induced C. difficile colitis prevention
Clostridioides difficile is an anaerobic bacteria. Not only does it thrive without oxygen, but oxygen is actually toxic to it. When exposed to oxygen it dies, leaving behind spores which can be thought of as really tiny hard-shelled nuts. They are dormant and very resilient.
These spores get into our digestive tract when we swallow contaminated food or air. When they reach the colon which has little oxygen, they germinate which is analogous to a seed nut sprouting.
Under normal circumstances our colon’s microbiome, a community of micro-organisms (bacteria, fungi, viruses, phages), crowds out the germinated C. difficile cells, preventing them from multiplying sufficiently to cause disease. Think of this like throwing out walnuts onto a messy overgrown lawn of grass and weeds. You probably won’t get any walnut trees.
Antibiotics are the foundation of modern medicine. They are used to cure otherwise potentially fatal bacterial infections of the bladder, kidney, skin, lungs, abdomen, and blood. They allow us to safely perform complex surgeries, organ transplants, chemotherapy for cancer, and treat autoimmune diseases where the body's immune system is compromised.
Unfortunately, antibiotics are also toxic to the bacteria in our colon, disrupting our microbiome, decreasing it’s ability to protect us from a C. difficile infection. This is analogous to plowing the aforementioned lawn, which kills some of the weeds and grass and loosens the soil so that the walnuts sprout and take root to make trees.
Once an infection takes root C. difficile produces toxins and causes inflammation that result in diarrhea, pain, dehydration, kidney failure, toxic megacolon, bowel perforation, colectomy, sepsis and death. Anybody can get C. difficile colitis, though some are at more risk than others. A single dose of any antibiotic can cause C. difficile colitis, though some antibiotics are riskier than others.
Urgent Public Health Threat
A half million Americans will get antibiotic-induced C. difficile colitis this year and 30,000 will die. There is no prevention. Big pharma has tried and failed to develop a vaccine. The infection is hard to cure and highly recurrent.
The CDC considers C. difficile an urgent public health threat.
Forty billion daily doses of antibiotics are prescribed each year globally. Two hundred seventy million antibiotic prescriptions are issued in the USA each year. Eighteen million hospitalized Americans will receive antibiotic therapy this year. These people need protection.
LPOXY Therapeutics is developing SIDIFENS to be taken with antibiotics to prevent antibiotic-induced C. difficile colitis. SIDIFENS is an orally-administered, metered-dose intestinal oxygen delivery therapeutic that gently raises colon oxygen levels.
Inflammatory Bowel Disease
Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that primarily affects the lining of the large intestine (colon) and rectum. It is characterized by the development of long-lasting inflammation and ulcers (sores) on the innermost lining of the colon. The symptoms of ulcerative colitis can vary but often include abdominal pain, cramping, diarrhea (which may contain blood), urgency to defecate, and weight loss. The exact cause of UC is unknown, but it is believed to result from an abnormal response of the immune system to normal bacteria in the digestive tract, combined with genetic and environmental factors. The condition can have periods of remission (when symptoms are absent) and flare-ups (when symptoms become worse).
Treatment aims to reduce inflammation, manage symptoms, and induce and maintain remission, which may include medication, lifestyle changes, and sometimes surgery. Treatments can range from anti-inflammatory drugs (such as amino salicylates and corticosteroids) to immunosuppressants and biologics that target specific pathways of the immune system to reduce inflammation. The choice of medication depends on the severity and extent of the disease. can range from anti-inflammatory drugs (such as aminosalicylates and corticosteroids) to immunosuppressants and biologics that target specific pathways of the immune system to reduce inflammation. The choice of medication depends on the severity and extent of the disease.
Many current treatments, especially corticosteroids and some immunosuppressants, can have serious side effects, including increased risk of infections, bone density loss, and impacts on liver and kidney function. Safer oral treatments are needed.
Crohn’s Disease
Crohn's disease is a type of inflammatory bowel disease (IBD) that can affect any part of the gastrointestinal tract, from the mouth to the anus, though it most commonly affects the end of the small intestine (ileum) and the beginning of the colon. It is characterized by inflammation that extends deep into the layers of the affected bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The inflammation caused by Crohn's disease can be both painful and debilitating, and it may lead to life-threatening complications.
The exact cause of Crohn's disease is unknown, but it is thought to result from a combination of genetic, environmental, and immune system factors. The immune system's abnormal response may trigger inflammation in parts of the gastrointestinal tract in genetically predisposed individuals. Unlike ulcerative colitis, which is limited to the colon and rectum, Crohn's disease can cause patchy areas of inflammation (skip lesions) throughout the entire digestive system.
There is currently no cure for Crohn's disease, but treatments are available that can significantly reduce its symptoms and even bring about long-term remission. These treatments include medication, lifestyle changes, and sometimes surgery to remove damaged portions of the gastrointestinal tract. The goal of treatment is to reduce inflammation, relieve symptoms, prevent complications, and improve quality of life.
There is a significant need for safer, oral treatments for Crohn's disease. Current treatments for Crohn's disease include a range of options, from anti-inflammatory drugs and immunosuppressants to biologics and corticosteroids, many of which have potential side effects and risks, especially with long-term use. Existing medications can have significant side effects, such as increased risk of infections, liver damage, bone density loss, and increased risk of certain cancers.
Clinical research has demonstrated oxygen’s impressive effectiveness in treating inflammatory bowel diseases
For over 90 years clinical research has demonstrated oxygen’s effectiveness (≥90%) in treating flare-ups of inflammatory bowel disease when administered via rectal insufflation or hyperbaric chambers. LPOXY Therapeutics is developing SIDIFENS to to help maintain remission and prevent flare-ups of inflammatory bowel disease. SIDIFENS is an orally-administered, metered-dose intestinal oxygen delivery therapeutic that gently raises colon oxygen levels.
Multiple Sclerosis
An estimated 2.5 million people are living with multiple sclerosis, an incurable neurological condition. About 200 new cases are diagnosed each week in the U.S.A. MS occurs when the immune system attacks the protective sleeve surrounding nerve fibers and brain cells, known as a myelin sheath, resulting in an intractable breakdown of the nervous system.
Mounting scientific evidence is demonstrating that epsilon toxin-producing Clostridium perfringens may be the long sought-after trigger that degrades the blood-brain barrier and kicks off the relentless inflammation and brain cell degradation characteristic of multiple sclerosis.
C. perfringens is an anaerobic pathogen that causes gas gangrene, food poisoning and enteritis necroticans (Pigbel). Oxygen is toxic to C. perfringens and inhibits clostridial toxin production, making SIDIFENS a potential MS treatment.
If you concerned about your personal diagnosis or treatment, please talk to your health care provider immediately regarding your specific medical needs. LPOXY Therapeutics does not give medical advice, nor do we provide medical or diagnostic services. If you have or suspect you have a medical problem or condition, contact a qualified health care professional.
For more information about our use and development of enteric aerobization therapy, contact us.