Synlogic Presents Data from Phase 1/2a Study of SYNB1618 at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) - Seite 2

In summary:

• A statistically significant increase in biomarkers of SYNB1618 activity (TCA and HA) was observed in both healthy volunteers and PKU patients treated with SYNB1618, but not in subjects treated with placebo, indicating that SYNB1618 was able to carry out its designed function and consume Phe in the human GI tract.
• Equivalent biomarker production and tolerability were observed in both patients and healthy volunteers at a dose of 7 x 10¹⁰ colony forming units (CFU) supporting the evaluation of a solid oral formulation of SYNB1618 in a bridging study in healthy volunteers to inform dosing in a subsequent efficacy study in patients.
• Evidence of activity in the human GI tract of the second Phe-consuming function engineered into SYNB1618 (LAAD) was provided by data from healthy volunteers.
• There were no treatment-related serious adverse events (SAEs), treatment-emergent AEs were either mild or moderate in severity. Most were GI-related, mild and reversible.
• All subjects cleared the bacteria in the expected time frame. There was no evidence of colonization, and no subject required antibiotics.
• Blood Phe levels were measured in all PKU patients over the course of the study. However, the study was not designed or powered to demonstrate Phe lowering.

In addition to the presentation highlighting results of the Phase 1/2a study of SYNB1618, Synlogic presented a poster describing a mathematical model for the relationship of blood Phe lowering with decreasing Phe levels in the GI tract as a result of reduced dietary Phe intake. The model can be used to estimate the potential effects of Phe consumption by SYNB1618 on blood Phe lowering in PKU patients.

SYNB1618 Clinical Development Plans and Upcoming Milestones
Synlogic has developed a robust and reproducible process and manufactured a new solid formulation of SYNB1618 that maintains strain viability and activity. Synlogic is currently evaluating this new formulation in an ongoing bridging study in healthy volunteers. A solid oral formulation of SYNB1618 with improved quality attributes may enable dosing to higher activity in a larger out-patient efficacy study in patients. Synlogic expects to initiate the SYNB1618 efficacy study in the first half of 2020.