StemCell Therapy

CAMBRIDGE, Mass., April 01, 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 data from its phenylketonuria (PKU) and homocystinuria (HCU) programs will be highlighted in two poster presentations at the Society for Inherited Metabolic Disorders (SIMD) 43rd Annual Meeting being held April 10-13, 2022 in Orlando, Florida.

Poster Presentations:

Abstract title (#70): Activity of SYNB1353, an Investigational Methionine-Consuming Synthetic Biotic Medicine, in an Acute Nonhuman Primate Model of Homocystinuria. Description: This presentation includes preclinical findings for SYNB1353, Synlogics drug candidate for HCU announced in November 2021, and shows significant blunting of plasma methionine and plasma homocysteine in response to an oral methionine load. Presenter: Mylene Perreault, PhD, SynlogicAbstract title (#74): Comparison of Phenylalanine Absorption in Healthy Volunteers and PKU Patients in the Synpheny-1 Study. Description: This presentation includes clinical data regarding the activity of SYNB1618 and SYNB1934, drug candidates in development for PKU, in metabolizing and reducing post-meal plasma levels of phenylalanine (Phe). Presenter: Marja Puurunen, MD, PhD, Synlogic

The poster presentations will be available in the Scientific Posters section of the Presentations and Publications page on the Synlogic website on April 11, 2022.

AboutSynlogic

Synlogicis a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogics 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 Synlogics proprietary, reproducible, target-specific drug design.Synlogicuses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases.Synlogicis 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 Synlogics approach to Synthetic Biotics with Ginkgos Codebase and Foundry services. For additional information visit http://www.synlogictx.com.

About SYNB1353

SYNB1353 is a novel orally administered, non-systemically absorbed drug candidate designed to consume methionine in the gastrointestinal tract thereby lowering homocysteine levels in patients with homocystinuria (HCU). HCU is an inherited disorder characterized by high levels of homocysteine and risks including thromboembolism, lens dislocation, skeletal abnormalities, developmental delay, and intellectual disability. Treatment options for HCU are currently limited due to efficacy and tolerability. SYNB1353 is currently in IND-enabling studies and was developed as part of a research collaboration withGinkgo Bioworks.Synlogicholds worldwide development and commercialization rights to SYNB1353, which is expected to begin clinical development and report Phase 1 data in healthy volunteers in H2 2022.

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 toSynlogic,may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential ofSynlogic'sapproach to Synthetic Biotics to develop therapeutics to address a wide range of diseases including: inborn errors of metabolismand inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotics; the approachSynlogicis taking to discover and develop novel therapeutics using synthetic biology; and the expected timing ofSynlogic'sclinical 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 ofSynlogicto protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading "Risk Factors" inSynlogic'sfilings with theSEC. The forward-looking statements contained in this press release reflectSynlogic'scurrent views with respect to future events.Synlogicanticipates that subsequent events and developments will cause its views to change. However, whileSynlogicmay elect to update these forward-looking statements in the future,Synlogicspecifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representingSynlogic'sview as of any date subsequent to the date hereof.

SOURCESynlogic, 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

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Synlogic to Present Data on Phenylketonuria and Homocystinuria Programs at the Society for ... - KULR-TV

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