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ABI-201 is an orally administered, genetically engineered live biotherapeutic product (LBP) developed for the treatment of phenylketonuria (PKU). Developed by ActoBio Therapeutics (a subsidiary of Precigen), the therapeutic utilizes the company's proprietary Actobiotics platform, which employs the food-grade bacterium *Lactococcus lactis* as a delivery vehicle. The bacteria are modified to express phenylalanine ammonia-lyase (PAL), an enzyme that degrades the amino acid phenylalanine into trans-cinnamic acid and trace amounts of ammonia within the gastrointestinal tract. By metabolizing phenylalanine before it can be absorbed into the bloodstream, ABI-201 aims to lower systemic phenylalanine levels and mitigate the neurological complications associated with PKU. The drug is designed to provide a non-invasive, oral alternative to current enzyme replacement therapies and strict dietary management.
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