Synlogic Announces Data Presentations from Five Programs at the 2022 Synthetic Biology: Engineering, Evolution & Design (SEED) Conference

Rhea-AI Summary

Synlogic, Inc. (Nasdaq: SYBX) announced its presentations at the 2022 SEED conference, taking place May 2-5 in Arlington, VA. These include an oral presentation detailing the progress of Synthetic Biotic drug candidates for metabolic diseases such as phenylketonuria (PKU) and homocystinuria (HCU). The conference will showcase preclinical and clinical data across five programs. With a focus on synthetic biology, Synlogic aims to address significant medical needs through innovative biotherapeutics.

Positive

• Oral presentation on Synthetic Biotic candidates for PKU and HCU scheduled for May 4, 2022.
• Positive evidence of clinical efficacy for SYNB1934 in PKU, with plans for a Phase 3 study in H2 2022.
• SYNB1353 and SYNB8802 are progressing towards clinical development, supporting Synlogic's diverse therapeutic pipeline.

Negative

• Treatment options for PKU are currently limited, with significant unmet patient needs.
• Clinical development timelines are subject to uncertainty, including potential delays.

CAMBRIDGE, Mass., April 26, 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 its planned presentations at the 2022 Synthetic Biology: Engineering, Evolution & Design (SEED) conference being held May 2-5, 2022, in Arlington, VA. The oral presentation outlines Synlogic’s progress in developing Synthetic Biotic drug candidates for rare metabolic diseases phenylketonuria (PKU) and homocystinuria (HCU), both inborn errors of metabolism. The poster presentations highlight preclinical and clinical data across five different Synlogic programs. Presentation details are provided below.

“The preclinical and clinical data being presented at SEED this year represent the remarkable progress we have achieved through our Synthetic Biotic programs to date in multiple therapeutic categories,” said Synlogic’s Chief Scientific Officer David Hava, PhD. “These presentations highlight the breadth and versatility of Synlogic’s application of synthetic biology to biotherapeutics, by targeting GI-based metabolites across different diseases to provide meaningful new treatment options with the potential to address important medical needs.”

Oral Presentation:

• Title: Engineered E. coli Nissle for the Treatment of Inborn Errors of Amino Acid Metabolism
  Author: Vincent Isabella, PhD, Synlogic
  Date: May 4, 2022
  Session: Therapeutic Bacteria (session #7)

Poster Presentations:

• Title: Engineering E. coli Nissle 1917 to Consume Uric Acid in the GI Tract
  Author: Sean Cotton, Synlogic
  Date and Time: May 2, 2022 from 4:00-5:00 PM ET (Poster session A)

• Title: A Synthetic Biotic, SYNB8802, Lowers Urinary Oxalate in Preclinical Models and Healthy Volunteers with Induced Dietary Hyperoxaluria
  Author: David Lubkowicz, PhD, Synlogic
  Date and Time: May 2, 2022 from 4:00-5:00 PM ET (Poster session A)

• Title: Biosensor-Enabled Optimization of SYNB1934, a Synthetic Biotic for Phenylketonuria Demonstrating Clinical Efficacy
  Author: Catherine Monahan, Synlogic
  Date and Time: May 2, 2022 from 4:00-5:00 PM ET (Poster session A)

• Title: Development of SYNB1353, A Synthetic Biotic Engineered to Consume Methionine for the Treatment of Homocystinuria
  Author: Jillian Means, Synlogic
  Date and Time: May 2, 2022 from 4:00-5:00 PM ET (Poster session A)

• Title: Local Delivery of Synthetic Biotics to Treat Inflammatory Bowel Disease
  Author: Aida Kalantari, PhD, Synlogic
  Date and Time: May 2, 2022 from 4:00-5:00 PM ET (Poster session A)

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.

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 with Synlogic and Gingko Bioworks. Synlogic holds 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 SYNB8802

SYNB8802 is a novel, orally administered, non-systemically absorbed drug candidate being developed for the treatment of enteric hyperoxaluria, a chronic, progressive disease characterized by high levels of urinary oxalate, the leading cause of recurrent kidney stones. Oxalate crystals can damage kidneys, leading to chronic kidney disease and end-stage renal disease (ESRD). SYNB8802 was designed using precision genetic engineering of the well-characterized probiotic E. coli Nissle to lower urinary oxalate levels by consuming oxalate throughout the GI tract. In 2021, Synlogic reported positive proof-of-mechanism for SYNB8802 from a Phase 1b study that demonstrated lowering of urinary and fecal oxalate levels in healthy volunteers with diet-induced hyperoxaluria. Data from a proof-of-concept study assessing the lowering of urinary oxalate in patients who have undergone Roux-en-Y gastric bypass surgery is expected in 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 Synlogic's focus at the 2022 SEED conference?

Synlogic will present on Synthetic Biotic drug candidates aimed at treating metabolic diseases like PKU and HCU.

When is the oral presentation scheduled?

The oral presentation is set for May 4, 2022.

What progress has Synlogic made with its drug candidates?

Synlogic has shown clinical efficacy for SYNB1934, with plans for a Phase 3 study in H2 2022.

What are the key drug candidates highlighted by Synlogic?

The key candidates include SYNB1618, SYNB1934, SYNB1353, and SYNB8802.

What medical needs does Synlogic aim to address?

Synlogic focuses on significant unmet medical needs for patients with metabolic and immunological diseases through innovative treatments.