Synlogic Presents Data on SYNB8802 for Enteric Hyperoxaluria at American Urological Association (AUA) Annual Meeting
- SYNB8802 was generally well tolerated in healthy volunteers. There were no serious or systemic adverse events. The most frequent adverse events were mild or moderate, transient, and GI-related.
- Dietary Hyperoxaluria was successfully induced in healthy volunteers.
- Dose-responsive changes in urinary oxalate levels were observed with a significant reduction in urinary oxalate relative to placebo across three dose levels.
- A dose of 3e11 live cells administered three times daily with meals was selected as the dose for Part B of the study.
- This dose was well-tolerated and resulted in a 28.6% (90% CI: -42.4 to -11.6) reduction from baseline urinary oxalate levels compared to placebo.
- At the end of dosing, the mean 24-hour urinary oxalate level was 40.1 mg for subjects treated with SYNB8802 3e11 live cells, compared to 58.1 mg for placebo subjects.
- Upper limit of normal urinary oxalate levels are 45 mg per 24 hours.
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About Enteric Hyperoxaluria
Enteric hyperoxaluria (HOX) is an acquired metabolic disorder caused by increased absorption of dietary oxalate, which is present in many common foods including leafy greens, nuts, and chocolate. Enteric hyperoxaluria often occurs as a result of a primary insult to the bowel, such as inflammatory bowel disease, Crohn's disease, short bowel syndrome, or as a result of surgical procedures such as Roux-en-Y bariatric weight-loss surgery.
Enteric hyperoxaluria results in dangerously high levels of urinary oxalate, which causes progressive kidney damage, kidney stone formation, and nephrocalcinosis. There are an estimated 250,000 patients with enteric hyperoxaluria in
SYNB8802 is an engineered non-pathogenic strain of E. coli (Nissle), using
Synlogic™ is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering,
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