Federation Bio, a biotechnology company pioneering bacterial cell therapies, announced that investigators have administered the first dose in a Phase 1 clinical study evaluating the company’s lead therapeutic candidate, FB-001, for the treatment of enteric hyperoxaluria.
FB-001 is an investigational, oral therapy consisting of 148 bacterial strains isolated from multiple healthy donors.
It is the first rationally designed complex consortium at this scale to enter clinical studies. The consortium leverages highly evolved microbes and is designed to perform multiple mechanisms of action including restoring gut-barrier function, limiting oxalate absorption, and robustly degrading dietary oxalate.
Federation Bio is evaluating FB-001 in enteric hyperoxaluria (EH), a metabolic disorder where increased absorption of oxalate in the gut can lead to recurrent kidney stones, chronic kidney disease, and end-stage renal disease (ESRD).
EH is a serious condition that affects approximately 250,000 people in the United States. There are no approved therapies for EH; the current standard of care relies on lifestyle interventions, which are associated with poor adherence and outcomes.
“FB-001 demonstrates the power of our first-in-class platform to design and manufacture extremely complex bacterial consortia that stably engraft to perform specific biological functions,” said Emily Drabant Conley, Ph.D., chief executive officer at Federation Bio. “These rationally designed consortia target multiple mechanisms in a single therapy, making them applicable to a wide range of diseases. The first-in-human clinical trial for FB-001 will evaluate a potential solution for patients with EH, who urgently need a treatment option that will fundamentally alter the course of their disease and prevent kidney function decline and eventual ESRD.”
FB-001 was manufactured using Federation Bio’s proprietary ACTTM (anerobic co-culture technology) platform. “Manufacturing a bacterial consortium of this complexity from individually purified cell lines is extremely complex and unprecedented,” said Lee Swem, Ph.D., chief scientific officer at Federation Bio. “Our ACTTM platform uniquely enables the production of highly controlled bacterial consortia that have been rationally designed to address a broad range of diseases and disorders.” The FB-001 Phase 1 clinical trial is a two-part study. Part 1 of the trial is placebo controlled and evaluates the safety and efficacy of FB-001 in 32 healthy volunteers with hyperoxaluria induced via diet. The key endpoints for this segment of the study are safety, engraftment of FB-001, and change in urinary oxalate vs. placebo. Interim study results are anticipated in mid-2023, after which Federation Bio will initiate Part 2 of the study to evaluate the safety and engraftment of FB-001 in patients with EH. Results of the trial will inform the design of a future Phase 2 trial.