Abstract: SA-PO689
Improvements in Calcific Uremic Arteriolopathy Wound Healing During SNF472 Treatment Assessed with the BWAT-CUA
Session Information
- Bone and Mineral Metabolism: Clinical - II
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Sinha, Smeeta, Salford Royal NHS Foundation Trust, Salford, United Kingdom
- Gould, Lisa, South Shore Hospital Center for Wound Healing, Weymouth, Massachusetts, United States
- Brandenburg, Vincent, University Hospital, Aachen, Germany
- Chertow, Glenn Matthew, Stanford University School of Medicine, Palo Alto, California, United States
- Miller, Stephan, Sanifit, San Diego, California, United States
- Garg, Rekha, Sanifit, San Diego, California, United States
- Gold, Alex, Sanifit, San Diego, California, United States
- Perelló, Joan, Laboratoris Sanifit, Palma de Mallorca, Spain
Background
Calcific uremic arteriolopathy (CUA/calciphylaxis) in patients with end-stage renal disease is a severe form of vascular calcification characterized by painful necrotic skin ulcers and very high mortality. No approved therapies are available. The investigational drug SNF472 is an intravenous formulation of myo-inositol hexaphosphate that inhibits formation and growth of hydroxyapatite crystals, the final common step in the pathophysiology of vascular calcification. A recent open-label, single-arm, 12-week Phase 2 trial of SNF472 in patients with CUA receiving hemodialysis demonstrated statistically and clinically significant improvements from baseline to end-of-study in wound healing, pain, and wound-related quality of life (NCT02790073).
Methods
14 patients with CUA were treated with SNF472 thrice weekly during each hemodialysis session for up to 12 weeks. We assessed effect on wound healing with the Bates-Jensen Wound Assessment Tool (BWAT), a 13-item, objective, quantitative tool originally developed and validated for the assessment of pressure ulcers. Based on the expert opinion of specialists in plastic surgery, wound care, and nephrology (all experienced in the care of patients with CUA) we derived a targeted modification of the BWAT using 8 items focused on prototypical features of CUA lesions: necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, and granulation tissue.
Results
Mean (SE) BWAT-CUA improved from 21.2 ± 2.0 at baseline to 14.9 ± 1.4 at Week 12 (p<0.002). Among the individual BWAT items, the largest improvements were observed for peripheral tissue induration, skin color surrounding wound, and granulation tissue.
Conclusion
BWAT-CUA is an objective and quantitative tool targeted for evaluation of CUA lesions and will be used in the upcoming Phase 3 randomized controlled trial of SNF472 for CUA.
Funding
- Commercial Support – Sanifit