Phase 3 Study of SNF472 for Calciphylaxis

Inclusion Criteria:

• Female or male subjects, 18 years of age or older
• Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
• Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulcerationof the epithelial surface
• CUA wound-related pain shown by a Pain VAS score ≥50 out of 100
• Primary lesion that can be clearly photographed for the purpose of protocol-specifiedwound healing assessments.
• Willing and able to understand and sign the informed consent form and willing tocomply with all aspects of the protocol

Exclusion Criteria:

• History of treatment with bisphosphonates within 3 months of baseline
• Severely ill subjects without a reasonable expectation of survival for at least 6months
• Subjects with a scheduled parathyroidectomy during the study period
• Expectation for kidney transplant within the next 6 months based on Investigatorassessment or identification of a known living donor
• Pregnant or trying to become pregnant, currently breastfeeding, or of childbearingpotential (including perimenopausal women who have had a menstrual period within oneyear) and not willing to comply with protocol required contraception criteria
• Significant noncompliance with dialysis
• History of active malignancy within the last year with the exception of localizedbasal cell or squamous cell carcinoma
• Clinically significant illness other than CUA within 30 days
• Participation in an investigational study and receipt of an investigational drug orinvestigational use of a licensed drug within 30 days prior to screening.
• History or presence of active alcoholism or drug abuse as determined by theInvestigator within 6 months
• Mental impairment, current significant psychiatric disease, or other conditions orcircumstances that would make the subject unlikely to complete the study or complywith the study procedures.
• Subjects whose CUA lesions exhibit significant improvement, in the opinion of theInvestigator, between the first and second screening visit