SUMMIT, N.J., June 24, 2026 /PRNewswire/ — Vascarta Inc., a clinical-stage biopharmaceutical company advancing innovative treatments for pain and inflammation, announced today the successful completion of the sublingual arm of its Phase I clinical trial evaluating VAS-101 (Vasceptor®; topical curcumin gel) for the treatment of sickle cell disease (SCD). The study was conducted by the Foundation for Sickle Cell Disease Research (FSCDR) in Hollywood, Florida, under the supervision of the principal investigator, Dr. Gershwin Blyden. The findings were published today in the Journal of Sickle Cell Disease: Low-Dose Sublingual Curcumin Improves Red Blood Cell Sickling Kinetics in Sickle Cell Disease: Interim Results from a Pilot Study | Journal of Sickle Cell Disease | Oxford Academic
Five (5) patients with sickle cell disease were treated sublingually with a minimal dosing (0.1 mL) of VAS-101 twice per week for a total of 8 treatments. Their blood was drawn and analyzed weekly. The duration of treatment was 29 days. All participants demonstrated favorable safety and tolerability. Directional improvements were observed across several patient-reported outcomes. Mean pain scores decreased from 7.0 at baseline to 6.6 by Day 15, with several participants demonstrating clinically meaningful reductions from baseline. Measures of fatigue and energy also improved, with out-of-energy scores decreasing from 3.6 at baseline to 2.2 by Day 22 and fatigue limits improving from 2.8 to 2.0.
Psychosocial ePRO measures showed stability or improvement across most participants, including reductions in worry, loneliness, and depressive symptoms. Assessment of red blood cell (RBC) functional biomarkers demonstrated improvements as measured by the DSA. From baseline to Day 29, the Area Under the Curve (AUC10) decreased from 419±140 to 394±118 %*min. Morphological Point of Sickling at 50% (mPoS@50%) increased from 4.9±1.0 to 5.5±1.2 minutes, indicating a delay in sickling. Additionally, the rate of sickling decreased from 47±23 to 38±17 %/min.
Collectively, these changes reflect improved sickling kinetics over the treatment period. FA-WB-VCAM and FA-WB-Psel adhesion indices (fAI) were below previously established critical thresholds (FA-WB-VCAM:400 cells/mm2, FA-WB-Psel:50 cells/mm2) predictive of future self-reported vaso-occlusive crises, VOCs in four (4) subjects at baseline and, as expected, no improvements in adhesion were seen at Day 29. Only a single participant exhibited a baseline FA-WB-VCAM fAI exceeding the clinical threshold (>502 cells/mm²).
Red blood cell mechanical fragility indices (MFI) were within normal range at baseline and remained stable over the course of the study. Baseline concentrations of standard inflammatory markers were and remained below the lower limit of detection for the initial three participants; consequently, further analytical testing was suspended.
VAS-101 demonstrated safety and tolerability in the sublingual cohort. Improvements in integrated ePRO and RBC functional biomarkers were noted suggesting potential mechanistic and patient-centered benefits of VAS-101 in individuals with SCD. The resulting biomarkers shift at low dose supports advancement towards dose optimization. Future studies evaluating higher dose and frequency may yield greater improvements in pain, ePRO measures, and laboratory biomarkers. Pre-selecting a cohort that exhibits a higher adhesive burden, indicative of more inflammation may show further improvements in RBC health normalization.
Dr. Lanetta Bronté, President of FSCDR, commented,
“I’m proud that we are taking part in Vascarta’s pilot study, which explores a new transdermal approach to pain management for individuals living with Sickle Cell Disease (SCD). 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. At FSCDR, we are committed to advancing care and bringing hope to the SCD community through innovation and collaboration.”
About VAS-101
VAS-101 (developed by Vascarta Inc., Summit, NJ) is a topical curcumin formulation that employs a patented transdermal delivery technology designed to increase bioavailability. Note: Curcumin possesses many beneficial attributes such as safety, anti-sickling, anti-inflammatory, and antioxidant properties, but its translational potential has been constrained due to limited bioavailability from oral administration. It is being clinically evaluated in several chronic inflammatory indications.
Unmet Need In Sickle Cell Disease
Sickle cell disease is the most common inherited genetic disorder that effects primarily African American and non – Hispanic Black individuals in the United States. SCD associated complications include anemia, acute and chronic pain, infections, pneumonia and acute chest syndrome, stroke, and kidney, liver, and heart disease.
Current estimates indicate there are >165,000 cases of SCD in the USA & 45,000 in European Union countries. The estimated life expectancy of those with sickle cell disease in the USA is more than 20 years shorter than the average expected lifespan.
SCD is caused by a single point mutation in the globin gene leading to sickling of red blood cells. It is characterized by severe pain, inflammation, oxidative stress, and organ damage, which contribute to the poor quality of life and reduced survival. Recently approved SCD therapies do not mitigate pain and patients are often on multiple drugs which often have undesirable side effects.
The unmet medical need for most SCD sufferers is significant. Better therapies that optimize compliance are appropriate for patients of all ages, minimize the need for blood transfusions, and reduce the need for chronic administration of potentially harmful pain medications are needed.
Leadership Perspectives
Dr. Richard Prince, Vascarta Chairman, CEO & President commented, “We are excited at the prospect of bringing relief to SCD sufferers who have limited therapeutic options. VAS-101 has the potential to become the new standard of care in the management of SCD. Independent of the FSCDR clinical findings presented herein, we have made VAS-101 (Vasceptor®) available to patients – given the well-recognized safety profile of curcumin – through a single 503A compounding pharmacy provided these patients obtain a prescription from a US-licensed physician. These results, in aggregate, are promising. We are working towards filing an Investigational New Drug Application with FDA later this year in furtherance of our VAS-101 sickle cell clinical development program.”
Dr. Joel Friedman, Emeritus Professor, Department of Microbiology & Immunology, Albert Einstein College of Medicine, and Vascarta Scientific Founder & Chief Science Officer is the inventor of VAS-101 which is exclusively licensed to Vascarta from the Albert Einstein College of Medicine (Bronx, New York, USA). He underscores the powerful potential of VAS-101: “The preclinical and clinical results to date demonstrate pain reduction and therapeutic efficacy resulting from our novel approach of targeting red blood cell instability, neuro-inflammation and vascular inflammation.” Dr. Friedman noted an anecdotal but exceptional result from “a sickle cell patient who had been suffering intense severe pain upon onset of menstruation. Sublingual administration of Vasceptor®, obtained through a Ramsey, New Jersey-based 503A compounding pharmacy, caused her pain to subside and remain pain-free until her next period, whereupon the pattern repeats. It is now 12 consecutive months and Vasceptor® has maintained the same analgesic effect for this patient. These clinical advances support the development of Vasceptor® as a potential therapy to prevent and treat many of the clinical sequelae of SCD.”
About Vascarta
Vascarta is a clinical stage pharmaceutical company exploring efficient transdermal delivery of pharmaceuticals to address inflammation and pain with an initial focus on sickle cell disease and osteoarthritis. More information can be found at www.vascarta.com or by email to:
- Dr. Richard Prince, Chairman, CEO & President – rprince@vascarta.com
- Media inquiries: David Hymson at dhymson@vascarta.com
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SOURCE Vascarta Inc.
