Why Are Synlogic Shares Moving Higher Premarket Monday?

• Synlogic Inc (NASDAQ: 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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