Synlogic Announces Publication of Synpheny-1 Phase 2 Study of Synthetic Biotic for Phenylketonuria in Nature Metabolism

CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company advancing novel, oral, non-systemically absorbed biotherapeutics to transform the care of serious diseases, today announced the publication of results from its Synpheny-1 Phase 2 study of its drug candidates, labafenogene marselecobac (SYNB1934) and SYNB1618 in patients with phenylketonuria (PKU) in the journal Nature Metabolism.

The publication, entitled “Efficacy and Safety of a Synthetic Biotic for Treatment of Phenylketonuria: a Phase 2 Clinical Trial” is now available online at https://www.nature.com/articles/s42255-023-00897-6. The paper includes a comprehensive review of the data, showing clinically meaningful, dose-dependent reductions in plasma phenylalanine (Phe).

“These positive results build on a body of data supporting the role of labafenogene marselecobac for patients with PKU,” said Dr. Neal Sondheimer, Head of Clinical Development at Synlogic. “These findings re-enforce our urgency to complete Synpheny-3, the pivotal trial now underway, and advance this potential new treatment to the many patients who need it.”

The study was completed with the participation of clinical teams at University of Pittsburgh, Mount Sinai Hospital, Washington University, Oregon Health & Science University, University of Texas-Houston, Vanderbilt University, University of Colorado and University of Florida.

About labafenogene marselecobac (SYNB1934)

Labafenogene marselecobac (SYNB1934) is an orally administered, non-systemically absorbed, potential treatment for phenylketonuria (PKU), a rare metabolic disease caused by inherited mutations that impair the breakdown of phenylalanine (Phe), an amino acid found in all protein-containing foods. The goal of PKU management is to reduce plasma Phe below neurotoxic levels, reducing risk of neurocognitive complications. Current treatment options for PKU are limited due to safety and efficacy, leaving the majority of people living with PKU without medical management and with uncontrolled Phe. Synlogic designed labafenogene marselecobac by applying precision genetic engineering to a well-characterized probiotic to target and consume Phe in the GI tract. Results to date indicate the potential for labafenogene marselecobac as the first therapeutic for PKU approved as both a monotherapy and adjunctive medical treatment, and following successful Phase 2 results, it has advanced to Synpheny-3, a global, pivotal Phase 3 study. Labafenogene marselecobac has received Orphan Drug Designation (ODD), Fast Track designation and Rare Pediatric Disease Designation (RPDD) from the FDA in addition to orphan designation from the European Medicines Agency (EMA).