CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) — Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today summarized accomplishments for 2022 and outlined anticipated key milestones for 2023.
The Company is expected to begin its Phase 3 trial in PKU in the first half of this year. In addition, SYNB1353 was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the potential treatment of HCU. RPDD is granted to drugs which are under development for rare childhood diseases. 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.
“With three positive clinical readouts in three different diseases in the fourth quarter, 2022 was an extraordinary year for Synlogic in terms of advancing the potential for Synthetic Biotics to become transformative medicines,” said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. “We are delighted to continue the momentum in 2023 as we look towards initiation of Synpheny-3, the pivotal Phase 3 study for SYNB1934 in PKU, and also appreciate the recent granting of Rare Pediatric Disease Designation for SYNB1353 for HCU by the FDA.”
2022 Accomplishments
Major program and corporate milestones achieved in 2022 included the following:
- Positive Phase 2 top-line data readout for PKU program, confirming SYNB1934 to advance to Phase 3
- Proof of concept achieved with Phase 1b top-line data for SYNB8802 for enteric hyperoxaluria
- Completion of Phase 1 study for SYNB1353 for HCU, achieving proof of mechanism
- Research milestone achieved from collaboration with Roche for novel Synthetic Biotic for the treatment of inflammatory bowel disease (IBD)
- SYNB2081 named as new drug candidate for the treatment of gout
- Positive Opinion on Orphan Designation received from the European Medicines Agency for SYNB1618 for PKU
- Fast Track designation, Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) received for SYNB1353 for HCU
Anticipated 2023 Milestones
- Initiation of Phase 3 clinical trial of SYNB1934 for PKU in H1 2023
- Presentation of full data from Phase 2 PKU study
- Advancing SYNB1353 to Phase 2 study in patients with HCU
- Presentation of data from Phase 1b studies of SYNB8802, in development for enteric hyperoxaluria
- Progression of preclinical pipeline programs, including partnerships
The Company also confirms that its current cash balance is expected to take the company into H2 2024. Synlogic will also report its 4Q and full year 2022 financial results in March 2023.
About Synlogic
Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to 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.
