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 (GLOBE NEWSWIRE) — 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 [email protected].
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.
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