Synlogic (SYBX) Announces SYNB8802 Will Advance to Phase 1B Proof of Concept Study After Proof of Mechanism Demonstrated in Dietary Hyperoxaluria

March 24, 2021 4:18 PM EDT

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Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that SYNB8802 has achieved proof of mechanism in a Dietary Hyperoxaluria study in which healthy volunteers on a high oxalate and low calcium diet were treated with multiple ascending doses of SYNB8802.

In the study's efficacy analysis, the percent change from baseline urinary oxalate levels were -28.6% (90% CI: -42.4 to -11.6), compared to placebo, at the 3e11 live cell dose. This dose was well tolerated and will be used in Part B of the study.

Synlogic has initiated Part B of the study and will assess the urinary oxalate lowering potential of SYNB8802 in patients with Enteric Hyperoxaluria following Roux-en-Y gastric bypass surgery. Data is expected in the second half of 2021.

"Enteric Hyperoxaluria is a debilitating condition with no approved treatment options," said Richard Riese, M.D., Synlogic's Chief Medical Officer. "Lowering dangerously high levels of urinary oxalate is the only way to reduce the risk of disease progression and irreversible kidney damage. We are pleased that SYNB8802 has demonstrated meaningful lowering of urinary oxalate levels in healthy volunteers with induced Dietary Hyperoxaluria. We are advancing the program rapidly into patients and will provide additional data this year."

"At Synlogic, we are building a portfolio of Synthetic Biotic medicines that consume toxic metabolites to provide new treatment approaches for patients struggling to manage their disease," said Aoife Brennan, M.B. Ch.B., Synlogic's President and Chief Executive Officer. "Only 15 months after we nominated SYNB8802 as a program, we are moving into a proof-of-concept patient study, demonstrating the speed and power of the Synthetic Biotic platform. We look forward to advancing additional metabolic product candidates to provide new treatment options for patients."

SYNB8802 Phase 1A Study: Design and ResultsThe primary outcome of Part A of the Phase 1 study was safety and tolerability, with results used to select a dose for further study in patients with Enteric Hyperoxaluria in Part B of the trial. Synlogic has completed dosing of five cohorts in part A, 45 total subjects. Findings include:

  • 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.
    • Subjects placed on 600 mg of daily dietary oxalate had urinary oxalate levels of 44.8 mg/24h at baseline.
  • 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 change from baseline urinary oxalate reduction of 28.6% (90% CI: -42.4 to -11.6), 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.

Full results of the study will be presented at a future medical meeting.

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