Synlogic Granted FDA Fast Track Designation for SYNB1353 for the Treatment of Homocystinuria (HCU)
The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. To qualify, available clinical and non-clinical data need to demonstrate meaningful therapeutic potential. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a registrational filing for approval on a rolling basis, and eligibility for priority review, if relevant criteria are met. SYNB1353, an orally-administered, non-systemically absorbed drug candidate designed to consume methionine in order to lower homocysteine levels, is currently being evaluated in a Phase 1 study in healthy volunteers.
“The FDA’s Fast Track designation reinforces our conviction for the urgent need for new treatments for HCU as well as the promising non-clinical data we have generated in the program to date,” said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. “We look forward to sharing additional data from the program later this year.”
HCU is an inherited disorder characterized by high levels of homocysteine and risks including thromboembolism, lens dislocation, skeletal abnormalities, developmental delay, and intellectual disability. Treatment options for HCU are currently limited due to efficacy and tolerability. SYNB1353 is an engineered strain of the probiotic bacteria E. coli Nissle which consumes methionine within the gastrointestinal tract, preventing methionine absorption and conversion to homocysteine in plasma. It is the first drug candidate developed through a research collaboration between Synlogic and Ginkgo Bioworks and the first investigational medicine developed on Ginkgo's platform to enter the clinic. In 2021, Synlogic shared preclinical data for SYNB1353 that demonstrated the lowering of blood homocysteine levels in non-human primates and mouse models. Synlogic expects to share results from the Phase 1 study of SYNB1353 in healthy volunteers by the end of 2022.
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) and enteric hyperoxaluria. 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 immunologic 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.
SYNB1353 is a novel orally-administered, non-systemically absorbed drug candidate designed to consume methionine in the gastrointestinal tract thereby lowering homocysteine levels in patients with homocystinuria (HCU). HCU is an inherited disorder characterized by high levels of homocysteine and risks including thromboembolism, lens dislocation, skeletal abnormalities, developmental delay, and intellectual disability. Treatment options for HCU are currently limited due to safety, efficacy, and tolerability. Synlogic holds worldwide development and commercialization rights to SYNB1353 and is expected to report Phase 1 data in healthy volunteers in H2 2022.
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Source: Synlogic, Inc.