WALTHAM, Mass. and BEVERLY HILLS, Calif., June 22, 2021 /PRNewswire/ -- CorEvitas, LLC and The Guthy-Jackson Charitable Foundation (GJCF) announce rst patient enrollment in the SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions in NMOSD) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD). CorEvitas is the leading sponsor of registries in autoimmune and inflammatory diseases, and the SPHERES launch expands its real-world-evidence registries established in rheumatology, dermatology, gastroenterology, and neurology. The SPHERES Registry is a collaboration between GJCF and CorEvitas designed to comprehensively study treatment efficacy and safety with a goal of enhancing outcomes for patients with NMOSD. CorEvitas and GJCF are actively inviting sites and patients to join the registry, which has an enrollment goal of approximately 800 NMOSD patients across a network of academic and private neurology practices.
"First patient enrollment is a milestone achievement in the SPHERES study to understand and improve clinical outcomes in the new era of approved NMOSD therapeutics. SPHERES will also facilitate quantum leaps in the eld, including the GJCF Relapse Navigator to standardize relapse adjudication and severity. In turn, these advances will create new opportunities to discover and apply clinical, therapeutic and laboratory correlates in NMOSD to promote remission and improve patient lives," said Dr. Michael Yeaman, Professor of Medicine at the David Geffen School of Medicine at UCLA and Chair Medical Advisor to the GJCF.
NMOSD is a rare neuroinflammatory autoimmune disease of the central nervous system, primarily targeting the optic nerves, spinal cord and brain. It is currently estimated to afflict approximately 15,000 people in the U.S. and hundreds of thousands worldwide. Historically, this disease has imposed significant physical and emotional disability and life-threatening outcomes.
Today, advances in diagnosis, biomarkers and newly FDA-approved treatment options offer patients with NMOSD promise to lessen or prevent disability and enhance quality of life.
"We are grateful for the expertise and partnership of the GJCF in achieving this meaningful milestone and are deeply committed to advancing the understanding of neurologic diseases through real-world evidence generation," said Dr. Jeff Greenberg, Chief Medical Officer of CorEvitas.
The study will evaluate the real-world effectiveness and safety of newly approved medications and their impact on quality of life and patient-reported outcomes. The SPHERES Registry is currently supported by Genentech, a member of the Roche group, and Horizon Therapeutics and represents their commitment to collaborative programs that benefit people living with NMOSD and their families. CorEvitas and GJCF look forward to additional industry partners joining this collaboration in the near future. To learn more about the SPHERES Registry, visit www.corevitas.com/contact-us.
About The Guthy-Jackson Charitable Foundation (GJCF)
Since 2008, The Guthy-Jackson Charitable Foundation has dedicated more than $68 million to funding clinical and basic science research aimed at understanding and solving NMOSD. As part of its field-transforming blueprint, GJCF designed and led the CIRCLES Registry, created the International Clinical Consortium for NMOSD including more than 112 world experts from 32 countries, formed the NMOSD Industry Council, organized the International Panel on NMOSD Diagnosis, engaged FDA in support of new therapies, and published a body of high-impact papers in leading journals, among other high-impact initiatives. As a result, the first-ever approved NMOSD therapies — along with quantum leaps in patient quality of life, improved diagnostics, biomarker identification, advances in epidemiology, and pioneering tolerization clinical trials—are now realities. The GJCF passionately supports programs that elevate public awareness of NMOSD through education and advocacy for patients, caregivers and healthcare providers. Together with its partners, these breakthroughs exemplify the GJCF mission to minimize the burden of NMOSD through prevention, rapid diagnosis, safe and effective treatments, and ultimately cures for this disease. Learn more at guthyjacksonfoundation.org.
CorEvitas is the built for purpose gold-standard provider of real-world evidence. Through syndicated registry data and analytic services, CorEvitas helps biopharmaceutical companies demonstrate the value of their products to clinicians, patients, payers, and regulators. CorEvitas operates nine major autoimmune registries across the US, Canada, and Japan, collecting data from over 500participating investigator sites. In addition to supporting hundreds of manuscripts and abstracts, CorEvitas has supported post approval safety commitments for multiple newly approved treatments in autoimmune diseases for both U.S. and European regulators. CorEvitas is headquartered in Waltham, MA. Its patient experience division, HealthiVibe, complements and strengthens the company's strong presence in disease registries by providing market-leading expertise in supporting innovative, evidence-based patient engagement initiatives across the product lifecycle. CorEvitas' HealthUnlocked technology platform hosts over 1.4M patients in hundreds of condition-specific communities and significantly expands the scope of patient experiential data. Health iQ, CorEvitas' EMR and Database Research division, provides access to a broad range of UK and international data sets across primary and secondary care, as well as deep relationships with the NHS and leading UK academic institutions. CorEvitas is a portfolio company of Audax Private Equity.
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SOURCE CorEvitas, LLC