Exhibit 99.1
Synlogic Receives Rare Pediatric Disease Designation from FDA for SYNB1934 for Phenylketonuria (PKU)
Cambridge, Mass. January 19, 2023 – Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that SYNB1934 was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the potential treatment of phenylketonuria (PKU).
“This designation for SYNB1934 demonstrates the urgent need for new PKU treatment options for patients, especially children,” said Dave Hava, Head of Research and Development. “This is also extraordinary news as our program heads towards initiation of Synpheny-3, the pivotal Phase 3 study for SYNB1934 in PKU in the first half of the year.”
Synlogic also received RPDD for SYNB1353 for the potential treatment of homocystinuria (HCU) in December 2022.
About Rare Pediatric Disease Designation
The FDA grants RPDD for serious and life-threatening diseases that primarily affect individuals from birth to 18 years old and fewer than 200,000 persons in the U.S. RPDD means that the sponsor may be entitled to receive a pediatric priority review voucher (pPRV) if the drug is initially approved for that rare childhood disease.
About Synlogic
Synlogic is the leading company advancing therapeutics based on synthetic biology. Synlogic’s pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the first half of 2023, and additional novel drug candidates designed to treat homocystinuria (HCU), enteric hyperoxaluria and gout. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogic’s reproducible, target-specific drug design. Synlogic uses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunological diseases. In addition to its clinical programs, Synlogic has a research collaboration with Roche on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease or IBD. Synlogic has also developed two drug candidates through a research collaboration with Ginkgo Bioworks: SYNB1353, designed to consume methionine for the potential treatment of HCU, and SYNB2081, designed to lower uric acid for the potential treatment of gout. For additional information visit www.synlogictx.com.
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