Synlogic Outlines Upcoming Clinical Milestones

CAMBRIDGE, Mass., Jan. 11, 2021 /PRNewswire/ -- Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today outlined significant clinical milestones for 2021 and provided an overview of recent progress.

"With three programs in clinical trials, multiple proof of concept opportunities, and a preclinical portfolio advancing rapidly towards the clinic, Synlogic is poised for success with a number of data readouts coming in 2021," said Aoife Brennan, M.B. Ch.B., Synlogic's President and Chief Executive Officer. "2020 was a year we will not forget. Despite the external challenges, the Synlogic team moved our programs forward with grit and resilience. We enter 2021 with momentum and the opportunity to truly see the potential of novel Synthetic Biotic medicines to make a meaningful difference in patients' lives."

Synlogic anticipates clinical proof of concept data in 2021 across two metabolic programs, SYNB1618 for the treatment of Phenylketonuria (PKU) and SYNB8802 for the treatment of Enteric Hyperoxaluria, as well as continued advancement of SYNB1891 for the treatment of solid tumors and lymphomas.

Execution Across Clinical Pipeline: Metabolic Programs

    --  Progression of a proof of concept Phase 2 clinical trial of SYNB1618 for
        the treatment of Phenylketonuria (PKU)
        --  SYNB1618 is an investigational drug composed of a Synthetic Biotic
            medicine designed to consume phenylalanine (Phe) in the
            gastrointestinal (GI) tract for the treatment of PKU in patients
            regardless of age or disease type.
        --  A solid oral formulation of SYNB1618 has been shown to metabolize
            Phe in the GI tract in a healthy volunteer study.
        --  The SynPheny-1 study evaluates plasma Phe lowering of SYNB1618 in
            adult PKU patients who do not benefit from, or do not tolerate,
            existing therapies such as Kuvan or Palynziq.
        --  Synlogic anticipates data from SynPheny-1 will be available mid-
            2021.

    --  Progression of a Phase 1 clinical study of SYNB8802 for the treatment of
        Enteric Hyperoxaluria
        --  SYNB8802 is an investigational drug composed of a Synthetic Biotic
            medicine designed to consume oxalate in the GI tract and lower
            urinary oxalate levels, potentially reducing kidney damage due to
            Enteric Hyperoxaluria.
        --  In data presented at the American Society of Nephrology's (ASN) 2020
            Kidney Week, SYNB8802 was shown to reduce urinary oxalate in two
            animal models of Hyperoxaluria.
        --  The Phase 1 clinical study evaluates the safety, tolerability, and
            potential for urinary oxalate lowering in healthy volunteers and
            patients.
        --  The study has two parts: Part A is a multiple ascending dose study
            in healthy volunteers; Part B is a placebo controlled, cross-over
            design study in patients with Enteric Hyperoxaluria following
            Roux-n-Y gastric bypass surgery which provides an opportunity to
            demonstrate proof of concept.
        --  Synlogic anticipates data from Part B of the study will be available
            mid-2021.

Execution Across Clinical Pipeline: Immunomodulation Programs

    --  Advancement of SYNB1891 into combination arm dosing with PDL1 checkpoint
        inhibitor in ongoing Phase 1 study
        --  SYNB1891 is an investigational drug composed of an intratumorally
            delivered Synthetic Biotic medicine designed to produce a STING
            agonist and act as a dual innate immune activator for the treatment
            of advanced solid tumors and lymphoma.
        --  SYNB1891 is currently being evaluated in a Phase 1 study that has
            two parts:
            --  Part A is a monotherapy arm that has enrolled four dose cohorts
                to date.
                --  A maximum tolerated dose has not been reached and dose
                    escalation continues.
            --  Part A of the study has demonstrated target engagement and
                activation of the STING pathway.
            --  Part B of the study will combine escalating dose levels of
                SYNB1891 with a fixed dose of the PD-L1 checkpoint inhibitor
                atezolizumab, to establish a recommended Phase 2 dose for the
                combination regimen.
        --  Synlogic anticipates additional data from cohorts in both arms will
            be available in mid to late 2021.

Preclinical Roadmap

    --  Synlogic continues to advance preclinical programs including additional
        effectors for immune-oncology; immune regulation targets for treatment
        of inflammatory bowel disease and other inflammatory disorders; and
        additional undisclosed rare metabolic diseases.
    --  Further updates on these programs will be shared as they advance towards
        the clinic.

2020 Corporate Milestones

    --  Synlogic strengthened leadership with the following appointments:
        --  Synlogic appointed Dr. David Hava, Ph.D., as Chief Scientific
            Officer. Dr. Hava brings over a decade of senior experience in
            research and development to Synlogic, including deep academic
            expertise in pillars of synthetic biology.
        --  Synlogic promoted Antoine 'Tony' Awad to Chief Operating Officer.
            Mr. Awad brings over 15 years of experience in the biotechnology and
            pharmaceutical industry with substantial experience in the
            development and manufacturing of novel therapeutics from pre-IND
            studies through global commercialization.
        --  Synlogic appointed Michael Heffernan, seasoned entrepreneur and
            biopharmaceutical leader, and Dr. Michael Burgess, physician
            scientist and expert in translational development, to its board of
            directors.
    --  Synlogic and Ginkgo Bioworks advanced their long-term strategic platform
        collaboration that provides expanded synthetic biology capabilities to
        Synlogic.
        --  Ginkgo and Synlogic are collaborating on multiple efforts including
            metabolic and immunomodulation programs, and assessment of the
            potential application of Synthetic Biotics for vaccine development.
    --  Synlogic ended the third quarter of 2020 with $102.0 million in cash,
        cash equivalents and short- and long-term investments and expects this
        will fund company operations through 2022 under its current plan.

Learn more about Synlogic's programs and pipeline by visiting https://www.synlogictx.com/.

About Synlogic
Synlogic(TM) is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX). The company is also building a portfolio of partner-able assets in immunology and oncology.

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 platform to develop therapeutics to address a wide range of diseases including: cancer, inborn errors of metabolism, and inflammatory and immune disorders; the future clinical development of Synthetic Biotic medicines; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials including the Phase 1 study for SYNB1891 and SYNB8802 and the Phase 2 study of SYNB1618, and availability of clinical trial data from that study and other studies.

Actual results could differ materially from those contained in any forward-looking statement 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.

View original content:http://www.prnewswire.com/news-releases/synlogic-outlines-upcoming-clinical-milestones-301204938.html

SOURCE Synlogic, Inc.