Benzinga | Sep 20, 2021 06:31AM EDT

Synlogic Announces Phase 2 Data Demonstrating Reduction In Plasma Phenylalanine Levels In Patients with Phenylketonuria

Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced positive data from clinical studies evaluating both SYNB1618 and SYNB1934, investigational Synthetic Biotic(tm) medicines for the treatment of phenylketonuria (PKU).

SYNB1618 demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels, across multiple time points, in an interim analysis of the Phase 2 SynPheny-1 study. 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.

Synlogic intends to incorporate SYNB1934 into an arm of the Phase 2 SynPheny-1 trial with final results expected in the first half of 2022. Based on the favorable clinical data from the SYNB1618 and SYNB1934 programs available to date, the Company intends to initiate planning for a pivotal Phase 3 study for the most promising strain.

"The PKU program demonstrated clear proof of concept in this analysis, with SYNB1618 achieving a clinically meaningful reduction of phenylalanine in patients across multiple endpoints and time points," said Aoife Brennan, M.B. Ch.B., Synlogic's President and Chief Executive Officer. "Additionally, our second PKU candidate SYNB1934 provides greater potency, which will allow us to optimize the clinical profile to address the profound needs of patients with PKU."

"Together, these data provide strong support for the ability of Synthetic Biotic medicines to make a meaningful difference to patients. These events mark a major milestone for Synlogic's Synthetic Biotic platform. We look forward to completing our Phase 2 SynPheny-1 study and advancing the PKU program into a pivotal study," continued Dr. Brennan.

"In addition to our strong clinical results, we're highly encouraged by the predictive validity of our prospective biomarker driven modeling of therapeutic effect," said David Hava, Ph.D., Chief Scientific Officer. "Patient clinical data observed to date was consistent with our preclinical predictions of Phe metabolism by the strains. The ability to translationally model clinical activity enables rapid and effective strain optimization, which we have applied both to PKU and other inherited and acquired metabolic disorders."