Synlogic Announces Data Presentations at the 2022 Genetic Metabolic Dieticians International (GMDI) Conference and Garrod Symposium

Rhea-AI Summary

Synlogic, Inc. (Nasdaq: SYBX), a biotechnology company specializing in synthetic biology, announced upcoming presentations of data from its phenylketonuria (PKU) program. Presentations include two posters at the Genetic Metabolic Dieticians International Conference from May 5-7, 2022, and a data presentation at the Garrod Symposium on May 13, 2022. Synlogic's lead program, SYNB1618, aims to provide effective treatment options for PKU patients, with plans for a pivotal Phase 3 study in the second half of 2022.

Positive

• Data presentations at two significant medical conferences enhance visibility for SYNB1618.
• SYNB1618 has received FDA Orphan Drug and Fast Track designations, indicating potential for accelerated approval.

Negative

• Limited treatment options remain for about 80% of PKU patients, highlighting a significant unmet medical need.

CAMBRIDGE, Mass., April 28, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced that the Company will present data from its phenylketonuria (PKU) program at two upcoming medical congresses focused on inborn errors of metabolism. These include two poster presentations at the Genetic Metabolic Dieticians International (GMDI) Conference being held May 5-7, 2022 in Lake Las Vegas, NV, and a data presentation at the Garrod Symposium being held May 12-14, 2022 in Calgary, Alberta, Canada. Details are provided below.

Genetic Metabolic Dieticians International (GMDI) Conference:

• Title: Dietary Management Outcomes During Synpheny-1, a Phase 2 Clinical Trial of a Live Biotherapeutic, SYNB1618, for the Management of Phenylketonuria
  Author: Nicole McWhorter, MS, RD,
  Date and time: May 5, 2022 from 5:30 – 7:00 P.M.

• Title: Characterization of Dietary Protein Intake in PKU Patients
  Author: Ken Ndugga-Kabuye, MD
  Date and time: May 5, 2022 from 5:30 – 7:00 P.M.

Garrod Symposium:

• Title: Reduction in Plasma Phenylalanine Levels in Patients with Phenylketonuria with Live Biotherapeutic SYNB1618: Interim Analysis from an Ongoing Phase 2 Study (Encore)
  Author: Marja Puurunen, MD, PhD
  Date and time: May 13, 2022 from 4:30 – 6:00 P.M.

The presentations will be available in their respective sections of the Presentations and Publications page on the Synlogic website on the day of the presentations.

About Synlogic 

Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogic’s pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the second half of 2022, and additional novel drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogic’s proprietary, reproducible, target-specific drug design. Synlogic uses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases. Synlogic is also working with Roche in a research collaboration focused on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease and with Ginkgo Bioworks to include additional undisclosed preclinical assets, combining Synlogic’s approach to Synthetic Biotics with Ginkgo’s Codebase and Foundry services. For additional information visit www.synlogictx.com.

About SYNB1618 and SYNB1934

SYNB1618 and SYNB1934 are orally administered, non-systemically absorbed drug candidates being studied as potential treatments for phenylketonuria (PKU), a genetic disease caused by potentially neurotoxic levels of the amino acid phenylalanine (Phe). Treatment options for PKU are currently limited due to efficacy and safety, with an estimated 80% of US patients remaining in need of treatment, and many of those who are treated in need of additional Phe-lowering. Synlogic designed drug candidates to reduce levels of Phe in people with PKU using precision genetic engineering of the well-characterized probiotic E. coli Nissle. Findings to date support the potential for an efficacious, safe, convenient, and flexible treatment option for PKU, and SYNB1618 has received both Orphan Drug and Fast Track designations by the US Food and Drug Administration (FDA). Both drug candidates are being studied in the Phase 2 SynPheny-1 study, with initiation of the Phase 3 program expected to begin in H2 2022.

Forward-Looking Statements

This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Synlogic, may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic's approach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolism and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials of SYNB1618, SYNB1934, SYNB1353 and SYNB8802 and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statements as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability of Synlogic to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading "Risk Factors" in Synlogic's filings with the SEC. The forward-looking statements contained in this press release reflect Synlogic's current views with respect to future events. Synlogic anticipates that subsequent events and developments will cause its views to change. However, while Synlogic may elect to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic's view as of any date subsequent to the date hereof.

SOURCE Synlogic, Inc.

Media Contact: 
Bill Berry
Berry & Company Public Relations
212-253-8881; bberry@berrypr.com 

Investor Contact: 
Andrew Funderburk
Kendall Investor Relations
617-914-0008; afunderburk@kendallir.com 

FAQ

What is the significance of the upcoming presentations for Synlogic (SYBX)?

The presentations will showcase data on SYNB1618, enhancing its visibility and potential market interest.

When is the next presentation for Synlogic's PKU program?

The presentations will occur at the Genetic Metabolic Dieticians International Conference from May 5-7, 2022.

What is SYNB1618's role in treating phenylketonuria?

SYNB1618 is being developed as a treatment for phenylketonuria, utilizing a live biotherapeutic approach.

What are the FDA designations for SYNB1618?

SYNB1618 has received both Orphan Drug and Fast Track designations from the FDA.

What is the timeline for Synlogic's Phase 3 study of SYNB1618?

The pivotal Phase 3 study for SYNB1618 is expected to begin in the second half of 2022.