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Synlogic Partners with Science 37 on Pivotal Study for Investigational Drug for Phenylketonuria (PKU)
Science 37's Metasite to Facilitate Phase 3 Study Enrollment by Expanding Access and Maximizing Convenience for Patients
RESEARCH TRIANGLE PARK, N.C., July 11, 2023—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 37
Science 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 Synlogic
Synlogic 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.
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