IP Library Granted Patent US 12,594,290
Granted Patent B2
US 12,594,290 · App. 19/065,860 · Granted Apr 7, 2026

IP and IP analogs dosage regimens for the treatment of ectopic calcifications

Inventors: Joan Perello Bestard (Palma de Mallorca, ES); Carolina Salcedo Roca (Palma de Mallorca, ES); Ana-Zeralda Canals Hamann (Palma de Mallorca, ES)
Assignee: SANIFIT THERAPEUTICS S.A.
A61K31/7024A61K9/0014A61K9/0019A61K31/6615A61K31/7032A61P9/00A61P17/02A61P19/08
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Quick Facts
Patent No.
US 12,594,290
App. No.
19/065,860
Granted
Apr 7, 2026
Kind
B2
Abstract

The present disclosure related to compositions, methods, dosages, dosage regimens, articles of manufacture and kits for the treatment and/or prevention ectopic calcifications, and in particular cutaneous calcifications such as calciphylaxis calcifications comprising inositol phosphate, inositol phosphate analogs, inositol phosphate derivatives, or combinations thereof. In a particular aspect the disclosure provides a dosage regimen to treat calciphylaxis comprising the administration of 6 mg/kg to 9 mg/kg daily doses of myo-inositol hexaphosphate, three times a week, for at least 1 to 8 months.

Claims (21)

1 . A method of treating or inhibiting the occurrence of aortic stenosis in a human subject in need thereof, comprising administering a dosage of about 5 mg to 10 mg of SNF472 (hexasodium salt of myo-inositol hexaphosphate) per kg per day, wherein the administration of the dosage effectively treats or inhibits the occurrence of aortic stenosis in the subject.

2 . The method of claim 1 , wherein the dosage is administered daily.

3 . The method of claim 2 , wherein the dosage is administered daily to the subject for about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 or 32 weeks.

4 . The method of claim 1 , wherein SNF472 is at least 90% pure.

5 . The method of claim 1 , wherein SNF472 is at least 95% pure.

6 . The method of claim 5 , wherein SNF472 is at least 99% pure.

7 . The method of claim 1 , wherein the dose of SNF472 is formulated for injection.

8 . The method of claim 7 , wherein the injection is an intravenous injection.

9 . The method of claim 8 , wherein the intravenous injection is a bolus injection.

10 . The method of claim 9 , wherein the intravenous injection is intravenous infusion.

11 . The method of claim 10 , wherein the administration is via slow or controlled release.

12 . The method of claim 1 , wherein the dosage is administered as a single daily dose or as multiple daily doses.

13 . The method of claim 1 , wherein the dosage is administered between 2, 3, 4, 5, 6, or 7 times per week.

14 . The method of claim 13 , wherein the dosage is administered 3 times per week.

15 . The method of claim 1 , wherein the dosage is administered for 12 weeks.

16 . The method of claim 1 , wherein the dosage is administered 3 days per week for 12 weeks.

17 . The method of claim 1 , wherein the subject has end-stage renal disease and/or is on hemodialysis.

18 . The method of claim 1 , wherein the dosage is administered via a dialysis apparatus.

19 . The method of claim 18 , wherein the dosage is administered before or after the filter of the dialysis apparatus.

20 . The method of claim 1 , wherein the administration of the dosage to the subject inhibits the formation and/or growth of hydroxyapatite crystals.

21 . The method of claim 1 , wherein the dosage of about 5 mg to 10 mg of SNF472 (hexasodium salt of myo-inositol hexaphosphate) per kg per day is a unit dose of about 6.0 mg/kg, about 7.0 mg/kg, about 8.0 mg/kg, about 9.0 mg/kg, about 9.7 mg/kg, or about 10 mg/kg.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2025
From: BESTARD, JOAN PERELLO; ROCA, CAROLINA SALCEDO; HAMANN, ANA-ZERALDA CANALS
To: SANIFIT THERAPEUTICS S.A.
Reel/Frame 073173/0560 →
NUNC PRO TUNC ASSIGNMENT Recorded Jul 8, 2025
From: SANIFIT THERAPEUTICS, S.A.
To: VIFOR (INTERNATIONAL) LTD.
Reel/Frame 071859/0562 →
Priority Claims (1)
ES ES201830988 · Oct 11, 2018 · national
Continuity (5)
Continuation 18778767 · Jul 19, 2024
Continuation 17192609 · Mar 4, 2021
Division 16791808 · Feb 14, 2020
Continuation PCTIB2018057904 · Oct 11, 2018
Related Publication 20250302853A1 · Oct 2, 2025
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Zabirnyk, A., et al., “SNF472, A Novel Anti-crystallization Agent, Inhibits Induced Calcification in an in Vitro Model of Human Aortic Valve Calcification,” Vascular Pharmacology 122-123:106583, Elsevier Science, United… [cited by applicant]