IP Library › Granted Patent US 12,312,308
Granted Patent B2
US 12,312,308 · App. 18/590,387 · Granted May 27, 2025

Salts and esters of APX3330 and therapeutic uses thereof

Inventors: Daniela Carmen Oniciu (Gainesville, FL); Corina-Mihaela Manta (Bucharest, RO); Anthony Carestia (Greensboro, NC); Jon Housley (Summerfield, NC)
Assignee: Opus Genetics, Inc.
C07C57/42C07C69/88C07B2200/13
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Quick Facts
Patent No.
US 12,312,308
App. No.
18/590,387
Granted
May 27, 2025
Kind
B2
Abstract

This invention relates to Compound 1 (APX3330) salts and esters. The invention also provides compositions comprising a Compound 1 salt or ester. The invention also provides compounds of formula (I) and formula (II) and pharmaceutically acceptable salts thereof. The invention further provides compositions comprising a compound of formula (I) or formula (II), or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier or vehicle. The invention also provides methods for treating or preventing a disease, such as cancer, a liver disorder, an ocular disorder, a cardiovascular disorder, fibrosis, or an inflammatory disorder, comprising administering to a subject in need thereof an effective amount of a Compound 1 salt or ester; or compound of formula (I) or formula (II), or pharmaceutically acceptable salt thereof.

Claims (27)

1. Compound 1 calcium salt that exhibits an X-ray powder diffraction (XRPD) pattern comprising a peak at 8.0±0.2 degrees 2-theta and a peak at 10.1±0.2 degrees 2-theta, wherein said Compound 1 calcium salt is a calcium salt of (2E)-2-[(4,5-dimethoxy-2-methyl-3,6-dioxo-1,4-cyclohexadien-1-yl)methylene]-undecanoic acid.

2. The Compound 1 calcium salt of claim 1 , wherein the XRPD pattern further comprises a peak at 13.3±0.2 degrees 2-theta or a peak at 14.6 degrees 2-theta.

3. The Compound 1 calcium salt of claim 1 , wherein the Compound 1 calcium salt exhibits an X-ray powder diffraction (XRPD) pattern comprising a peak at 5.1±0.2 degrees 2-theta, a peak at 8.0±0.2 degrees 2-theta, a peak at 10.1±0.2 degrees 2-theta, a peak at 13.3±0.2 degrees 2-theta, a peak at 14.6±0.2 degrees 2-theta, and a peak at 18.5±0.2 degrees 2-theta.

4. Compound 1 calcium salt that exhibits an XRPD pattern that is substantially the same as that depicted in FIG. 2 A , wherein said Compound 1 calcium salt is a calcium salt of (2E)-2-[(4,5-dimethoxy-2-methyl-3,6-dioxo-1,4-cyclohexadien-1-yl)methylene]-undecanoic acid.

5. The Compound 1 calcium salt of claim 1 , wherein the Compound 1 calcium salt is 95.0% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

6. The Compound 1 calcium salt of claim 1 , wherein the Compound 1 calcium salt is 98% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

7. A composition comprising the Compound 1 calcium salt of claim 1 , and a pharmaceutically acceptable carrier or excipient.

8. The Compound 1 calcium salt of claim 2 , wherein the Compound 1 calcium salt is 98% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

9. The Compound 1 calcium salt of claim 3 , wherein the Compound 1 calcium salt is 98% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

10. The Compound 1 calcium salt of claim 4 , wherein the Compound 1 calcium salt is 98% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

11. A composition comprising the Compound 1 calcium salt of claim 2 , and a pharmaceutically acceptable carrier or excipient.

12. A composition comprising the Compound 1 calcium salt of claim 3 , and a pharmaceutically acceptable carrier or excipient.

13. A composition comprising the Compound 1 calcium salt of claim 4 , and a pharmaceutically acceptable carrier or excipient.

14. A composition comprising the Compound 1 calcium salt of claim 5 , and a pharmaceutically acceptable carrier or excipient.

15. A composition comprising the Compound 1 calcium salt of claim 8 , and a pharmaceutically acceptable carrier or excipient.

16. A composition comprising the Compound 1 calcium salt of claim 9 , and a pharmaceutically acceptable carrier or excipient.

17. A composition comprising the Compound 1 calcium salt of claim 10 , and a pharmaceutically acceptable carrier or excipient.

18. The Compound 1 calcium salt of claim 1 , wherein the Compound 1 calcium salt is 99.9% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

19. The Compound 1 calcium salt of claim 2 , wherein the Compound 1 calcium salt is 99.9% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

20. The Compound 1 calcium salt of claim 3 , wherein the Compound 1 calcium salt is 99.9% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

21. The Compound 1 calcium salt of claim 4 , wherein the Compound 1 calcium salt is 99.9% pure by weight according to HPLC chromatogram, based on the HPLC chromatogram's relative peak area.

22. The Compound 1 calcium salt of claim 18 , wherein the purity is determined by HPLC at 262 nm.

23. A composition comprising the Compound 1 calcium salt of claim 18 , and a pharmaceutically acceptable carrier or excipient.

24. A composition comprising the Compound 1 calcium salt of claim 19 , and a pharmaceutically acceptable carrier or excipient.

25. A composition comprising the Compound 1 calcium salt of claim 20 , and a pharmaceutically acceptable carrier or excipient.

26. A composition comprising the Compound 1 calcium salt of claim 21 , and a pharmaceutically acceptable carrier or excipient.

27. A composition comprising the Compound 1 calcium salt of claim 22 , and a pharmaceutically acceptable carrier or excipient.

Assignments (8)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2026
From: OPUS GENETICS, INC.
To: APEXIAN PHARMACEUTICALS, INC.
Reel/Frame 075531/0886 →
SECURITY INTEREST Recorded Apr 21, 2026
From: OPUS GENETICS, INC.
To: OPCM SA LLC, AS PURCHASER AGENT FOR THE SECURED PARTIES
Reel/Frame 075478/0138 →
CHANGE OF NAME Recorded Jan 22, 2025
From: OCUPHIRE PHARMA, INC.
To: OPUS GENETICS, INC.
Reel/Frame 069987/0040 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2024
From: CARESTIA, ANTHONY; HOUSLEY, JON
To: CAMBREX HIGH POINT, INC.
Reel/Frame 067656/0848 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2024
From: ONICIU, DANIELA CARMEN
To: OCUPHIRE PHARMA, INC.
Reel/Frame 067655/0821 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2024
From: CAMBREX HIGH POINT, INC.
To: OCUPHIRE PHARMA, INC.
Reel/Frame 067657/0131 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2024
From: LUNGAN, MARIA-ANDREEA; PATRASCU, ANDREI-ALUNEL; MANTA, CORINA-MIHAELA
To: SARA PHARM SOLUTIONS S.R.L.
Reel/Frame 067655/0981 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2024
From: SARA PHARM SOLUTIONS S.R.L.
To: OCUPHIRE PHARMA, INC.
Reel/Frame 067656/0199 →
Continuity (3)
Continuation 18367631 · Sep 13, 2023
Provisional Application 63375647 · Sep 14, 2022
Related Publication 20240199523A1 · Jun 20, 2024
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