Synlogic (SYBX) Presents Data Demonstrating Activity of a Solid Oral Formulation of SYNB1618

April 13, 2021 9:23 AM EDT

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Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today presented data from the Phase 1 study of SYNB1618 for the treatment of Phenylketonuria (PKU) during the American College of Medical Genetics (ACMG) annual meeting, being held virtually April 13-16, 2021.

The poster presentation, "Randomized, Placebo-Controlled Study of Lyophilized Formulation of SYNB1618 in Healthy Adult Volunteers," was delivered by Dr. Marja Puurunen, Synlogic's Senior Medical Director. The presentation recording will be available throughout the duration of the conference.

PKU is an inherited metabolic disease that manifests at birth and is marked by an inability to break down phenylalanine, an amino acid that is commonly found in many foods. Left untreated, PKU can lead to serious neurological and neuropsychological problems.

SYNB1618 is an oral investigational Synthetic Biotic medicine designed to break down phenylalanine in the GI tract as a potential treatment for patients with PKU. A solid oral lyophilized powder formulation was evaluated in a Phase 1 study in healthy volunteers. In this study, the safety, tolerability and pharmacodynamics of multiple doses of SYNB1618 were assessed. Findings reported today include:

  • The solid oral formulation of SYNB1618 was well tolerated and metabolically active in the human GI tract.
  • SYNB1618 reduced the increase of plasma D5-Phe following an oral dose of the tracer in a dose-dependent manner in healthy volunteers.
  • SYNB1618 demonstrated evidence of activity in the fasted state i.e. without protein intake, suggesting an ability to metabolize non-dietary Phe in the GI tract.

These data support the further clinical development of this therapy for the treatment of PKU. SYNB1618 continues to advance in a proof of concept Phase 2 clinical trial in adults with PKU, SynPheny, with data expected in the second half of 2021.

Learn more about Synlogic's programs and pipeline by visiting

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