Synlogic Progresses Clinical and Preclinical Pipeline and Outlines 2018 Catalysts
January 05 2018 - 8:00AM
Business Wire
– Presentation of full clinical data from first
in-human study of Synthetic Biotic™ medicine expected in 1Q 2018
–
– IND for SYNB1020 for the treatment of
hyperammonemia in patients with liver disease has been cleared by
the FDA –
– Additional trials in patients with UCD and
PKU expected to begin in 2018 –
Synlogic (Nasdaq: SYBX), a clinical-stage company applying
synthetic biology to probiotics to develop novel living medicines,
today provided an overview of recent progress and outlined key
objectives and anticipated milestones for 2018.
“For Synlogic, 2017 was a landmark year in which we made
significant clinical progress with the completion of the
first-in-human trial of our Synthetic Biotic platform,” said J.C.
Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive
officer. “Importantly, this study in healthy volunteers provided
the first ever demonstration of a dose-dependent effect on a
systemic metabolite by an orally-administered living medicine which
functions in the gut. We demonstrated that our Synthetic Biotic
medicine was safe and well tolerated, and gained valuable
experience in manufacturing, dosing and clinical evaluation of this
new therapeutic modality. In 2018 we expect to present the full
data from this study and further validate the platform with several
clinical catalysts including the initiation of three clinical
trials in our two lead programs for hyperammonemia and
phenylketonuria.”
2018 Goals and Catalysts:
SYNB1020: An orally delivered, first-in-class, Synthetic Biotic
medicine designed for treatment of elevated blood ammonia levels
(hyperammonemia) in genetic urea cycle disorders (UCDs) or in
chronic liver disease.
- Plan to present full data from
Synlogic’s first-in-human clinical study evaluating SYNB1020 in
healthy volunteers at two medical meetings in the first quarter of
2018:
- Society for Inherited Metabolic
Disorders (SIMD) Annual Meeting – March 11-14, 2018, in San Diego,
CA.
- International Conference on Ureagenesis
Defects: Novel Models and Treatment Options – March 19-21, 2018, in
Engadin, Switzerland.
- Initiation of Phase 1b/2a study in
cirrhotic patients with elevated ammonia in the first quarter of
2018, with interim data expected by year-end. An Investigational
New Drug (IND) application has been cleared by the U.S. Food and
Drug Administration (FDA) enabling Synlogic to initiate this
clinical trial.
- Initiation of second Phase 1b/2a study
in UCD patients in mid-2018, with data expected in 2019.
SYNB1618: An orally delivered, Synthetic Biotic medicine
designed for the treatment of phenylketonuria (PKU)
- Initiation of Phase 1 SAD/MAD study in
healthy volunteers and PKU patients in the first half of 2018, with
interim data expected in the second half of 2018.
Pre-clinical data and early pipeline programs
- Additional data to be presented at
major scientific and medical meetings throughout the year
demonstrating the breadth of Synlogic’s Synthetic Biotic platform
in new indications, including data from the company’s research and
preclinical immuno-oncology program.
Corporate
- Advancement of collaborations with
AbbVie in inflammatory bowel disease (IBD) and Ginkgo in
neurological and liver disease.
- Continued exploration of additional
strategic opportunities to expand the platform’s reach.
2017 Accomplishments and Highlights:
SYNB1020:
- Granted Fast Track Designation from the
FDA in UCDs.
- Completed Phase 1 trial and reported
top-line data from healthy volunteers. The study demonstrated
safety and tolerability at doses up to 1.5 x 1012 CFU daily, as
well as proof-of-mechanism with a statistically significant,
dose-dependent effect on plasma nitrate in stable isotope tracer
studies using 15NH4Cl. These data suggest that, functioning from
the gut, SYNB1020 could potentially have a clinically meaningful
effect in patients with elevated blood ammonia levels.
SYNB1618:
- Granted Orphan Drug Designation from
FDA for treatment of PKU.
- Presented positive pre-clinical data at
the International Congress of Inborn Errors of Metabolism (ICIEM)
in support of further development of SYN1618 for the treatment of
PKU, and SYN-MSUD for the treatment of Maple Syrup Urine Disease
(MSUD).
Corporate
- Closed merger with Mirna Therapeutics
and successfully listed on Nasdaq exchange under ticker symbol
SYBX.
- Achieved first milestone in AbbVie
collaboration to develop Synthetic Biotic-based treatments for
IBD.
- Announced a strategic collaboration
with Ginkgo Bioworks to discover new living medicines to treat
neurological and liver disorders.
- Grew organization to support increased
clinical activity and expansion of development and manufacturing
capabilities, including key hires in corporate development, human
resources and legal departments which will support continued
evolution of the company as it advances its platform of Synthetic
Biotic medicines.
About Synthetic Biotic MedicinesSynlogic’s innovative new
class of Synthetic Biotic medicines leverages the tools and
principles of synthetic biology to genetically engineer probiotic
microbes to perform or deliver critical functions missing or
damaged due to disease. The company’s two lead programs target a
group of rare metabolic diseases – inborn errors of metabolism
(IEM). Patients with these diseases are born with a faulty gene,
inhibiting the body’s ability to break down commonly occurring
by-products of digestion that then accumulate to toxic levels and
cause serious health consequences. When delivered orally, these
medicines can act from the gut to compensate for the dysfunctional
metabolic pathway and have a systemic effect. Synthetic Biotic
medicines are designed to clear toxic metabolites associated with
specific metabolic diseases and have the potential to significantly
improve symptoms of disease for affected patients.
About SynlogicSynlogic is pioneering the development of a
novel class of living medicines, Synthetic Biotic medicines, based
on its proprietary drug development platform. Synlogic’s initial
pipeline includes Synthetic Biotic medicines for the treatment of
rare genetic diseases, such as urea cycle disorders (UCD) and
phenylketonuria (PKU). In addition, the company is leveraging the
broad potential of its platform to create Synthetic Biotic
medicines for the treatment of more common diseases, including
liver disease, inflammatory and immune disorders, and cancer.
Synlogic is collaborating with AbbVie to develop Synthetic
Biotic-based treatments for inflammatory bowel disease (IBD). For
more information, please visit www.synlogictx.com.
Forward-Looking StatementsThis 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, 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: inborn errors of metabolism, liver disease,
inflammatory and immune disorders, and cancer; the future clinical
development of Synthetic Biotic medicines; the approach Synlogic is
taking to discover and develop novel therapeutics using synthetic
biology; the potential of Synlogic’s technology to treat
hyperammonemia and phenylketonuria; the expected timing of
Synlogic’s anticipated clinical trial initiations; the advancement
of our collaborations, and the benefit of orphan drug status.
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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20180105005195/en/
SynlogicMEDIA:Courtney Heath,
617-872-2462courtney@scientpr.comorINVESTORS:Elizabeth
Wolffe, Ph.D., 617-207-5509liz@synlogictx.com
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