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Trial Underway for Kidney Disease Microbiome Therapy

Microbiome illustration

(Darryl Leja, National Human Genome Research Institute, NIH. Flickr: https://www.flickr.com/photos/genomegov/30395469313)

9 Dec. 2022. A clinical trial enrolled its first participant testing an engineered bacterial collection as a treatment for enteric hyperoxaluria, a kidney disorder with no approved cure. The study is conducted by the biotechnology company Federation Bio in South San Francisco, but is not yet listed in ClinicalTrials.gov, the U.S. government’s clinical trial registry.

Hyperoxaluria is a condition caused by too much oxalate in urine. Oxalate or oxalic acid is a natural metabolite from plants that in occasional consumption is not considered harmful. When excessive quantities of oxalates occur in the body, however, they can bind to minerals and accumulate in blood vessels, bones, and organs, particularly the kidney. Hyperoxaluria can result from a genetic condition, where the body does not produce an enzyme needed to prevent or limit oxalate formation. In cases where the the intestines absorb excessive amounts of oxalates, such as in people with intestinal disorders including Crohn’s disease, the condition is known as enteric hyperoxaluria.

People with hyperoxaluria often suffer from kidney stones and other kidney damage, leading to impaired kidney function and end-stage renal disease or ESRD and the need for dialysis. The Oxalosis and Hyperoxaluria Foundation says as many as 24 percent of people with intestinal diseases that absorb too much oxalate also have enteric hyperoxaluria. Federation Bio says some 200,000 people in the U.S. are affected by enteric hyperoxaluria. The condition is treated today mainly by lifestyle changes, such as drinking large quantities of water.

Federation Bio is developing engineered cell therapies that work in bacterial communities in the gut, also known as the microbiome. The company is commercializing research by its scientific founders Michael Fischbach and Dylan Dodd, professors of bioengineering and microbiology respectively at Stanford University. Federation Bio says its technology designs treatments for disease that activate and integrate multiple bacteria in the gut that affect T-cells in the immune system, for enteric hyperoxaluria as well as cancer and autoimmune disorders. In Oct. 2020, Science & Enterprise reported on the company’s formation and raising of $50 million in early venture funds.

Rationally designed bacterial consortia

Federation Bio’s lead product is a treatment for enteric hyperoxaluria code-named FB-001. The company says FB-001 is an oral drug that combines 148 bacterial strains from healthy donors, made with the company’s anerobic culture technology that engineers and produces genetically altered bacterial cell therapeutics in the absence of oxygen.

“Manufacturing a bacterial consortium of this complexity from individually purified cell lines is extremely complex and unprecedented,” says Federation Bio’s chief scientist Lee Swem in a company statement released through Cision. Swem adds that the company’s technology “enables the production of highly controlled bacterial consortia that have been rationally designed to address a broad range of diseases and disorders.”

Federation Bio says the early-stage clinical trial is enrolling 32 health volunteers who agree to consume a high volume of foods with oxalates to induce hyperoxaluria. Participants are randomly assigned to to take FB-001 or a placebo, with the study team looking for adverse effects as well as engraftment of FB-001 and changes in oxalate in urine samples. Based on initial results, the company plans to extend the study to patients with enteric hyperoxaluria or EH.

“The first-in-human clinical trial for FB-001 will evaluate a potential solution for patients with EH,” notes Federation Bio’s CEO Emily Drabant Conley, “who urgently need a treatment option that will fundamentally alter the course of their disease and prevent kidney function decline and eventual ESRD.”

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