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Abstract: SA-PO289

Outcomes Assessment in a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of SNF472 for Treating Calciphylaxis

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Sinha, Smeeta, Salford Royal NHS Foundation Trust, Salford, United Kingdom
  • Chertow, Glenn Matthew, Stanford University School of Medicine, Palo Alto, California, United States
  • Brandenburg, Vincent, Rhein-Maas Klinikum, Würselen, Germany
  • Gould, Lisa, South Shore Hospital Center for Wound Healing, Weymouth, Massachusetts, United States
  • Miller, Stephan, Sanifit Therapeutics, San Diego, California, United States
  • Salcedo, Carolina, Sanifit Therapeutics, Palma, Spain
  • Padgett, Claire S., Sanifit Therapeutics, San Diego, California, United States
  • Garg, Rekha, Sanifit Therapeutics, San Diego, California, United States
  • Gold, Alex, Sanifit Therapeutics, Palma, Spain
  • Perelló, Joan, Sanifit Therapeutics, Palma, Spain
Background

Calciphylaxis (calcific uremic arteriolopathy, CUA) is a severe form of vascular calcification characterized by painful necrotic skin ulcers and very high mortality. No approved therapies are available. SNF472, an intravenous formulation of myo-inositol hexaphosphate, inhibits formation and growth of hydroxyapatite crystals, the final common step in the pathophysiology of vascular calcification. The objective of this Phase 3 randomized, double-blind, placebo-controlled trial is to evaluate efficacy and safety of SNF472 for CUA. Efficacy outcomes will include wound healing, pain, and wound-related quality of life (QoL). Standard safety assessments will be conducted.

Methods

Planned enrollment is approximately 66 adult patients on maintenance hemodialysis with a clinical diagnosis of CUA with wound ulceration and wound-related pain. Patients will be randomized 1:1 to SNF472 (7 mg/kg) or placebo 3x/week for 12 weeks via infusion through the dialysis circuit. In a subsequent 12-week open-label period all patients will receive SNF472. Patients will also receive background care for CUA in accordance with the practices of each site.

Results

Wound healing will be assessed with the Bates-Jensen Wound Assessment Tool (BWAT), BWAT-CUA, and qualitative review of wound images. All 13 items comprising the BWAT will be assessed: size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding the wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, epithelialization. BWAT-CUA is an 8-item targeted modification of BWAT focused on prototypical features of CUA lesions including necrotic tissue type and amount, exudate type and amount, skin color surrounding the wound, peripheral tissue edema and induration, and granulation tissue. External, independent wound care experts blinded to treatment assignment will determine BWAT scores based on review of standardized images, measurements from imaging software, and assessments by site investigators. Pain will be assessed on a visual analog scale. QoL will be assessed with the Wound-QoL questionnaire.

Conclusion

Efficacy and safety of SNF472 for CUA will be evaluated.

Funding

  • Commercial Support –