Synlogic Reports Positive Interim Ph I/IIa Data for Microbiome Based Treatment for Phenylketonuria

Synlogic, Inc., (Nasdaq:SYBX) a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, today announced positive interim clinical data from the healthy volunteer (HV) arm of its ongoing Phase 1/2a study of SYNB1618 in HVs and patients with PKU. The first part of this trial, which evaluated SYNB1618 versus placebo (PBO) in single- (SAD) and multiple-ascending dose (MAD) cohorts of HVs, successfully met the study’s primary objectives, to demonstrate safety and tolerability of SYNB1618 in HVs and to identify a suitable dose to evaluate in patients with PKU. Consistent with preclinical studies, the Phase 1/2a clinical data demonstrated that oral administration of SYNB1618 resulted in significant dose-dependent production of biomarkers specifically associated with SYNB1618 activity, demonstrating proof-of-mechanism.

"The significant dose-dependent production of SYNB1618-specific biomarkers in healthy volunteers is an exciting first step towards delivering a potential therapy for patients with PKU,” said Aoife Brennan, M.B., B.Ch., Synlogic’s interim president and chief executive officer and chief medical officer. "We have identified a dose for the next phase of our ongoing trial in patients with PKU and we look forward to expanding on these interim results when we report top-line data from the patient treatment arm of this trial in mid-2019. Importantly, the data also demonstrate the potential for our Synthetic Biotic platform to address conditions in which an engineered living medicine can be designed to perform a specific metabolic function within the gastrointestinal tract."

Synlogic’s Synthetic Biotic platform leverages the tools and principles of synthetic biology to engineer a strain of probiotic bacteria (E. coli Nissle) to perform or deliver specific functions lost or damaged due to disease.

In addition to the PKU program, the company has nine additional therapies in various stages of development.

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