BOSTON, Sept. 15, 2022 (GLOBE NEWSWIRE) — Today, Folia Health announced the initiation of the ASCEND Study, a first-of-its-kind, at-home observational real-world evidence study in which people living with sickle cell disease (SCD) will use Folia’s innovative technology platform to track their individual changes in symptoms and treatment use. The ASCEND Study, which is currently enrolling patients, is being conducted by Folia Health with funding from Global Blood Therapeutics, Inc. (GBT).
The study will use Folia’s app and proprietary analytics methodology to measure outcomes in SCD with the aim of uncovering insights about the real-world experiences of individuals living with the condition, including the use of Oxbryta® (voxelotor), GBT’s first-in-class, once-daily oral therapy for the treatment of SCD.
ASCEND will capture and measure Home Reported Outcomes (HROs), enabling individuals with SCD, as well as their caregivers, to leverage their own observations and lived experience to better understand the impact of treatment and health events. No additional clinic visits will be required for patients participating in this study as all data collection will be conducted remotely.
“There is a significant need for more granular, patient-driven, high-quality data to understand the experience of individuals living with sickle cell disease and the impact of novel therapies like Oxbryta,” said Nell Meosky Luo, CEO and Founder of Folia Health. “In order for advancements in sickle cell disease to be better understood, we need to capture home-reported evidence that closes the gap between data from traditional endpoints collected in clinical trials and the real-world patient’s day-to-day experience. The ASCEND study will utilize the Folia mobile app or desktop platform to capture this evidence directly from patients in real time. We are thrilled to be working with GBT on such an exciting endeavor to better understand and measure the outcomes that matter to people living with SCD.”
SCD is a rare blood disorder that affects millions worldwide; in the United States, approximately 100,000 people have the disease.1 It is most prevalent among those of sub-Saharan African descent, and is also more likely to affect people of Hispanic, Middle Eastern, South Asian, and Southern European ancestry.1 SCD causes the production of “sickled” or abnormal hemoglobin, a protein carried by red blood cells that carries oxygen to the body.2 This abnormality in hemoglobin results in the formation of the characteristic sickle shape of red blood cells in its deoxygenated form, thus giving the disease its name.3 Unlike normal healthy red blood cells, the sickle shaped cells are sticky, rigid and, due to their characteristic shape, get stuck in blood vessels, blocking blood flow to organs and causing infections and enormous pain.2 Complications resulting from a sickle cell crisis, including stroke, acute chest syndrome, organ damage, other hip and joint complications, can be life-threatening and in some cases cause premature death.4
“GBT supports efforts to better comprehend and assess the experiences of patients with sickle cell disease,” said Alain Romero, PharmD, Ph.D., Senior Vice President and Head of Global Medical Affairs at GBT. “We hope that using the Folia Health platform in the ASCEND Study will deliver new insights by enabling sickle cell disease patients to track their experiences and participate in meaningful research from their home.”
Eligible participants include individuals age 13 and older who have been clinically diagnosed with SCD, and caregivers of children age 4 and older with SCD. To learn more about virtual study participation and to sign up, visit www.foliahealth.com/ascend.
About Folia Health
Folia is a patient-driven Health-IOS (Individual Operating System) that enables individuals to easily take an active role in their care, while contributing to precision diagnostics, patient-centered drug development, & better care for complex diseases. Folia’s rich longitudinal data and proprietary analytic methods provide a vital and missing piece in the emergence of a home-centered, data-driven healthcare ecosystem. Discover how to harness the power of patient and caregiver knowledge at www.foliahealth.com.
1. “Sickle Cell Disease Data and Statistics (SCD).” Centers for Disease Control and Prevention, https://www.cdc.gov/ncbddd/sicklecell/data.html.
2. Gardner RV. Sickle Cell Disease: Advances in Treatment. Ochsner J. 2018;18(4):377-389. doi:10.31486/toj.18.0076
3. Hahn EV, Gillespie EB. Sickle cell anemia. Report of a case greatly improved by splenectomy. Experimental study of sickle cell formation. Arch Intern Med (Chic). 1927. February:39(2):233-254. doi: 10.1001/archinte.1927.00130020072006
4. “Sickle Cell Disease.” Hematology.org, https://www.hematology.org/education/patients/anemia/sickle-cell-disease.
Folia Health Contact:
Amanda Healey (study-related)
Paula Mello Ferber (media)