Microbiome Therapeutics for Patients and Physicians - Medical / Health Care

Seres has announced positive topline results in the Phase 3 ECOSPOR III study of SER-109 in the treatment of C. difficile. Seres has completed enrollment in the SERES-013 ECOSPOR IV open-label study for SER-109.

Clostridioides difficile, formerly known as Clostridium difficile, or C. difficile, is one of the top 3 most urgent bacterial threats in the United States, according to the Centers for Disease Control and Prevention. It is the leading cause of hospital-acquired infection in the US and is responsible for the deaths of approximately 20,000 Americans each year.

The current standard of care for C. difficile infection is antibiotic treatment. However, antibiotic treatment alone is ineffective against dormant spore forms of C. difficile, which can germinate and grow after antibiotics are completed, leading to a vicious cycle of recurrence. Repeated antibiotic exposure also depletes beneficial bacteria that inhibit C. difficile, increasing the risk of recurrence.

SER-109 is an investigational oral microbiome therapeutic for the prevention of recurrent C. difficile infection. The FDA has granted SER-109 both Breakthrough Therapy and Orphan Drug designations.

Now enrolling: A Phase 1b study in Australia and New Zealand for patients with mild to moderate ulcerative colitis. Learn more: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380059 

Ulcerative colitis (UC) is a serious chronic condition marked by persistent inflammation in the digestive tract which can greatly reduce an individual’s quality of life. Although the pathogenesis of UC remains unclear, changes in the gastrointestinal microbiome and associated metabolites appear to be important. The relationship between the immune system and the gut microbiome also appears to play a role in the disease.

There is a clear need for new treatments for patients with mild to moderate UC. Anti-inflammatory compounds like 5-ASAs are used to reduce inflammation in mild to moderate UC patients, but they fail to induce remission in a significant proportion of patients. Corticosteroids are used to dampen the immune system and control flare-ups, but they carry toxicity risks that limit their long-term use. Patients who do not respond to early-stage treatments are likely to advance to biologic drugs and small molecules, which bring a high risk of side effects and may require IV delivery.

Seres has completed enrollment of a clinical trial of SER-287, an oral consortium of commensal bacteria designed to have pharmacological effects on the pathways driving UC.