Science 37 Holdings, Inc. (Nasdaq: SNCE), the clinical research
industry-leading Metasite™ has been chosen by Synlogic, (Nasdaq:
SYBX), a clinical-stage biotechnology company advancing novel oral,
non-systemically absorbed biotherapeutics to transform the care of
serious diseases in need of new treatment options. Synlogic chose
Science 37 to provide virtual clinical trial technology and
services for Synpheny-3, its ongoing pivotal, Phase III trial of
investigational drug labafenogene marselecobac (previously known as
SYNB1934) as a potential treatment for phenylketonuria (PKU), a
rare, genetic metabolic disorder.
The Synpheny-3 trial aims to study the effectiveness of
labafenogene marselecobac, an orally administered, investigational
medicine based on a genetically engineered probiotic, in PKU
patients. Synlogic anticipates enrolling approximately 150 patients
who have the potential to receive the investigational drug and to
be monitored for up to three years. The Science 37 Metasite will
expand access to the trial for patients who may be unable or prefer
not to travel to research sites for study visits. Science 37 will
also provide its unified platform to the study’s physical research
sites, ensuring end-to-end data quality and consistency, no matter
where or how data is captured.
“The approach to this study truly embodies patient centricity,”
said Dr. David Kudrow, Medical Director at Science 37. “We can
facilitate involvement for anyone interested in participating in
the trial, with little inconvenience, while ensuring and delivering
high-quality data to the sponsor.”
"We are delighted to partner with Science 37 on this
groundbreaking study," said Neal Sondheimer, Vice President, Head
of Clinical at Synlogic. "Their commitment to patient centricity,
innovative processes, and advanced technology will enable trial
participants to engage in the study in a manner that is most
convenient and effective for them, be it in-person, virtually, or a
combination of both."
About Science 37Science 37 Holdings, Inc.’s (Nasdaq: SNCE)
mission is to accelerate clinical research by enabling universal
trial access for patients. Through our Metasite™ we reach an
expanded population beyond the traditional site, delivering on our
goal of clinical research that works for everyone—with greater
patient diversity. Patients gain the flexibility to participate
from the comfort of their own homes, at their local community
provider, or at a traditional site when needed. Our Metasite is
powered by a proprietary technology platform with in-house medical
and operational experts that drive uniform study orchestration,
enabling greater compliance and high-quality data. To learn more,
visit www.science37.com, or email science37@science37.com.
About SynlogicSynlogic is a clinical-stage
biotechnology company advancing novel, oral, non-systemically
absorbed biotherapeutics to transform the care of serious diseases
in need of new treatment options. The Company’s late-stage pipeline
is focused on rare metabolic diseases, led by labafenogene
marselecobac (SYNB1934), currently being studied as a potential
treatment for phenylketonuria (PKU) in Synpheny-3, a global,
pivotal Phase 3 study. Additional product candidates address
diseases including homocystinuria (HCU), enteric hyperoxaluria,
gout, and cystinuria. This pipeline is fueled by the Synthetic
Biotic platform, which applies precision genetic engineering to
well-characterized probiotics. This enables Synlogic to create
GI-restricted, oral medicines designed to consume or modify
disease-specific metabolites – an approach well suited for PKU and
HCU, both inborn errors of metabolism, as well as other disorders
in which the disease–specific metabolites transit through the GI
tract, providing validated targets for these Synthetic Biotics.
Research activities include a partnership with Roche focused on
inflammatory bowel disease (IBD), and a collaboration with Ginkgo
Bioworks in synthetic biology, which has contributed to two
pipeline programs to date. For more information, please visit
www.synlogictx.com. To learn more about the Synpheny-3 study, visit
www.pkuresearchstudy.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws, including
statements regarding the products offered by Science 37 and the
markets in which it operates, and Science 37’s anticipated growth
and profitability. These forward-looking statements generally are
identified by the words “believe,” “can,” “could”, “seek”,
“project,” “expect,” “anticipate,” “estimate,” “intend,”
“strategy,” “future,” “opportunity,” “plan,” “may,” “might”,
“should,” “will,” “would,” “will be,” “will continue,” “will likely
result” and similar expressions. Forward-looking statements are
predictions, projections and other statements about future events
that are based on current expectations and assumptions and, as a
result, are subject to risks and uncertainties. Many factors could
cause actual future events to differ materially from the
forward-looking statements in this press release, including but not
limited to: (i) the ability to maintain the listing of Science 37’s
securities on The Nasdaq Stock Market LLC, (ii) volatility in the
price of Science 37’s securities due to a variety of factors,
including changes in the competitive and highly regulated
industries in which Science 37 operates, variations in performance
across competitors, changes in laws and regulations affecting
Science 37’s business, changes in its capital structure, and
general economic and financial market conditions, including
fluctuations in currency exchange rates, economic instability, and
inflationary conditions (iii) the ability to implement business
plans, forecasts, and other expectations, and to identify and
realize additional opportunities, (iv) the risk that Science 37 may
never achieve or sustain profitability, (v) the risk that Science
37 will need to raise additional capital to execute its business
plan, which may not be available on acceptable terms or at all,
(vi) failure to realize anticipated cost savings, and (vii) risks
related to general economic and financial market conditions. The
foregoing list of factors is not exhaustive. You should carefully
consider the foregoing factors and the other risks and
uncertainties described in the “Risk Factors” section of Science
37’s Annual Report on Form 10-K for the fiscal year ended December
31, 2022 filed with the U.S. Securities and Exchange Commission
(the “SEC”) on March 6, 2023 and in the other documents filed by
Science 37 from time to time with the SEC. These filings identify
and address other important risks and uncertainties that could
cause actual events and results to differ materially from those
contained in the forward-looking statements. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and Science 37 assumes no obligation and does not intend to update
or revise these forward-looking statements, whether as a result of
new information, future events, or otherwise, except as required by
law. Science 37 does not give any assurance that Science 37 will
achieve its expectations.
MEDIA INQUIRIES:Grazia MohrenScience 37PR@science37.com
Synlogicmedia@synlogictx.com
INVESTOR RELATIONS:Steve HalperLifeSci
AdvisorsInvestors@science37.com
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