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Synlogic Presents at Global PKU Patient Meeting

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On September 10, 2021, Synlogic (Nasdaq: SYBX) presented at the Global PKU Patient Meeting, discussing Synthetic Biotic medicines for Phenylketonuria (PKU). Key insights include that two-thirds of adult PKU patients and one-third of pediatric patients struggle to maintain target Phe levels on a low phenylalanine diet. Over 90% of patients expressed a desire to increase natural protein intake. The investigational drug SYNB1618, a Synthetic Biotic, aims to lower plasma Phe levels and is currently in Phase 2 trials. Future survey results will be shared at upcoming medical meetings.

Positive
  • SYNB1618 is in Phase 2 trials, demonstrating progress in drug development.
  • The investigational drug was found to be safe and well-tolerated in previous studies.
  • High patient interest (over 90%) in increasing natural protein intake suggests a market need for effective PKU treatments.
Negative
  • Two-thirds of adult PKU patients do not achieve target Phe levels despite treatment.
  • Existing therapies have not adequately addressed the needs of the patient population, indicating a potential market gap.

CAMBRIDGE, Mass., Sept. 10, 2021 /PRNewswire/ -- Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today presented on the development of investigational Synthetic Biotic medicines for the treatment of Phenylketonuria (PKU) at the Global PKU Patient Meeting, being held virtually September 10-11th, 2021.

The presentation, "Synthetic Biotic Medicines for the Treatment of PKU," was delivered by Dr. Marja Puurunen, M.D., Ph.D., Synlogic's Senior Medical Director and Head of Metabolic Programs, and included an overview of the SYNB1618 development program.

In addition, Synlogic presented findings from a survey of adult PKU patients and the caregivers of pediatric PKU patients on their experience with the low phenylalanine diet which remains the primary treatment for PKU. Findings from the survey include:

  • Two-thirds of adult and one-third of pediatric PKU patients do not have Phe levels within the target range, despite a restrictive low phenylalanine diet and treatment with currently available therapies.
  • Greater than 90% of patients and 95% of pediatric caregivers would like to increase the amount of natural protein in their diet.
  • More than 50% of adult respondents and more than 80% of pediatric caregiver respondents found 2-3 grams of additional natural protein per day "meaningful."
    • One slice of bread or one medium sized potato contains 2-3 grams of natural protein.

The survey was conducted through partnerships with the National PKU Alliance (NPKUA) of the U.S. and the Canadian PKU and Allied Disorders Inc (CanPKU). Complete survey results will be presented at a future medical meeting or in publication.

Patients can learn more about the SynPheny-1 study by visiting https://pkuresearchstudy.com. More information about Synlogic's programs and pipeline can be found at https://www.synlogictx.com.

About PKU
Phenylketonuria (PKU) is an inherited metabolic disease that manifests at birth and is marked by an inability to break down phenylalanine (Phe), an amino acid that is commonly found in many foods. Left untreated, high levels of Phe become toxic and can lead to serious neurological and neuropsychological problems affecting the way a person thinks, feels, and acts. Due to the seriousness of these symptoms, infants are screened at birth in many countries to ensure early diagnosis and treatment to avoid intellectual disability and other complications.

About SYNB1618
SYNB1618 is an investigational oral drug for the treatment of Phenylketonuria (PKU) composed of an engineered Synthetic Biotic designed to lower plasma phenylalanine (Phe) levels by consuming Phe in the GI tract. A solid oral lyophilized formulation of SYNB1618 was found to be safe and well-tolerated, and consumes Phe in the GI tract of healthy volunteers. Synlogic has initiated a Phase 2 study in PKU patients (NCT04534842).

About Synlogic
Synlogic™ 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. 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; our expectations about sufficiency of our existing cash balance; 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 of SYNB1618 and availability of clinical trial data including Phase 2 data of SYNB1618 for the treatment of PKU. 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.

Media Contact:

Investor Contact:

Daniel Rosan

Synlogic, Inc.

Phone: 617-401-9152

Email: dan.rosan@synlogictx.com

Daniel Rosan

Synlogic, Inc.

Phone: 617-401-9152

Email: dan.rosan@synlogictx.com

Cision View original content:https://www.prnewswire.com/news-releases/synlogic-presents-at-global-pku-patient-meeting-301373398.html

SOURCE Synlogic, Inc.

FAQ

What did Synlogic present at the Global PKU Patient Meeting on September 10, 2021?

Synlogic presented on Synthetic Biotic medicines for Phenylketonuria (PKU) and discussed findings from a survey of PKU patients regarding their treatment experiences.

What is SYNB1618 and its significance in PKU treatment?

SYNB1618 is an investigational oral drug designed to lower plasma phenylalanine levels in PKU patients and is currently in Phase 2 clinical trials.

What are the survey findings related to PKU patients presented by Synlogic?

The survey revealed that two-thirds of adult and one-third of pediatric PKU patients struggle to maintain target Phe levels on a low phenylalanine diet.

How effective are current PKU treatments according to Synlogic's survey?

The survey indicated that existing therapies do not meet the needs of the majority of PKU patients, with many desiring more natural protein intake.

Synlogic, Inc.

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