
The Foundation for Sickle Cell Disease Research (FSCDR) in Hollywood, Florida, will evaluate VAS-101, a topical curcumin gel, in an upcoming first in human, proof of concept, phase I clinical study in sickle cell disease (SCD). The study is under the supervision of principal investigator Gershwin T. Blyden, MD, PhD, FCP, FACP, medical director of FSCDR.
The study will include 10 patients treated with VAS-101 twice per week over 4 weeks. Over 29 days, five patients will receive topical treatment on their forearm and five will receive sublingual treatment.
The primary endpoints are safety, tolerability, and the effect of VAS-101 on impaired blood flow dynamics, including adhesion molecule expression and erythrocyte fragility parameters. Secondary endpoints include the effect of VAS-101 on inflammatory markers associated with sterile inflammation activation over 28 days, the average change in red blood cell sickling kinetics, and the pain-relieving benefit and opioid-sparing effect of VAS-101.
“Pain remains one of the most challenging and life-disrupting aspects of this disease, and new approaches are urgently needed. While early in development, this research represents an important step toward finding new options that could one day help ease that burden,” said Lanetta Bronté-Hall, MD, MPH, MSPH, President and Chief Health Officer of FSCDR, in a press release.
Reference
Vascarta commences proof of concept phase 1 clinical study of VAS-101 in sickle cell disease in the United States. Vascarta Inc. News release. April 15, 2025. Accessed April 22, 2025. https://www.prnewswire.com/news-releases/vascarta-commences-proof-of-concept-phase-1-clinical-study-of-vas-101-in-sickle-cell-disease-in-the-united-states-302428782.html