Why Are Synlogic Shares Moving Higher Premarket Monday?

  • Synlogic Inc SYBX has announced data from clinical studies evaluating SYNB1618 and SYNB1934 for phenylketonuria (PKU).
  • PKU is a rare genetic disease that manifests at birth and is characterized by an inability to break down phenylalanine, an amino acid commonly found in many foods. 
  • Interim analysis of Phase 2 SynPheny-1 study trial of SYNB1618 demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels across multiple time points. 
  • SYNB1934, an optimized strain evolved from SYNB1618, demonstrated two-fold higher activity than SYNB1618 in a head-to-head Phase 1 study in healthy volunteers, as measured by biomarkers of Phe metabolism.
  • The interim analysis of SYNB1618 included eight patients.
  • 20% reduction in fasting plasma Phe after 14 days of dosing, at a dose of 1e12 live cells was reported.
  • 40% reduction in labeled plasma D5-Phe after meal challenge at day 15, at a dose of 2e12 live cells, was seen.
  • A rebound of plasma Phe levels following cessation of dosing confirmed the therapeutic effect.
  • Synlogic plans to complete the SynPheny-1 study with a cohort of patients receiving SYNB1934 and anticipates final SynPheny-1 results in 1H of 2022.
  • The company intends to initiate a pivotal Phase 3 study of the most promising strain based on the clinical data.
  • Price Action: SYBX shares are up 6.38% at $3.50 during the premarket session on the last check Monday.
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