Synlogic has treated the first healthy volunteer in its Phase I study of SYNB8802, an engineered non-pathogenic strain of E coli (Nissle), for enteric hyperoxaluria (HOX).
Engineered using Synlogic’s Synthetic Biotic platform, the investigational medicine SYNB8802 consumes oxalate in the GI tract and lower urinary oxalate levels and can potentially reduce kidney damage due to enteric HOX.
Enteric hyperoxaluria is an acquired metabolic disorder caused by high absorption of dietary oxalate.
The disorder occurs due to a primary insult to the bowel, which can result in dangerously high levels of urinary oxalate, leading to progressive kidney damage, kidney stone formation, and nephrocalcinosis.
The Phase I two-part clinical study will evaluate SYNB8802’s safety and tolerability and its potential to reduce urinary oxalate.
Part A is a multiple ascending dose study in healthy volunteers, while Part B is a placebo-controlled, cross-over design study in patients with enteric hyperoxaluria following Roux-n-Y gastric bypass surgery.
Synlogic president and CEO Aoife Brennan said: “We are thrilled to be moving SYNB8802 into the clinic ahead of schedule.
“Leveraging our Synthetic Biotic platform allowed us to move rapidly from candidate declaration to the initiation of the Phase I study in under nine months.”
The data from the study is expected to be available next year.
Preclinical nonhuman primate and mouse models of acute hyperoxaluria showed that SYNB8802 significantly reduced oxalate levels at six hours relative to vehicle alone.
In-silico simulations of predicted human exposure hint that SYNB8802 can potentially achieve 20% to 50% urinary oxalate lowering in patients at doses that were well-tolerated in prior trials of synthetic biotic medicines.