synb1353

SYNB1353 is an investigational, orally administered, non-systemically absorbed live biotherapeutic product being developed by Synlogic and Ginkgo Bioworks for the treatment of classical homocystinuria (HCU). [3, 8] It is a genetically engineered strain of the probiotic bacterium *E. coli* Nissle, designed to consume the amino acid methionine in the gastrointestinal (GI) tract. [1, 6] By breaking down methionine, SYNB1353 aims to prevent its absorption and subsequent conversion into homocysteine, a substance that accumulates to toxic levels in patients with HCU. [1, 3] This metabolic disorder is caused by a deficiency in the cystathionine beta-synthase (CBS) enzyme. [3, 4] The U.S. FDA has granted SYNB1353 both Orphan Drug Designation and Fast Track designation. [3]