IP Library Granted Patent US 10,975,090
Granted Patent B2
US 10,975,090 · App. 16/806,819 · Granted Apr 13, 2021

Crystalline forms of therapeutic compounds and uses thereof

Inventors: Elizabeth Enlow (Waltham, MA); Minh Ngoc Nguyen (Dorchester, MA); Winston Z. Ong (Stoneham, MA)
Assignee: Kala Pharmaceuticals, Inc.
C07D491/107A61K9/0048A61K9/10A61K9/14A61K9/146A61K9/5021A61K31/517A61K47/10A61K9/0034C07B2200/13
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Quick Facts
Patent No.
US 10,975,090
App. No.
16/806,819
Granted
Apr 13, 2021
Kind
B2
Abstract

Described herein are certain crystalline forms of Compound 3, as well as pharmaceutical compositions employing the crystalline forms. Also provided are particles (e.g., nanoparticles) comprising such crystalline forms or pharmaceutical compositions. In certain examples, the particles are mucus penetrating particles (MPPs). The present invention further relates to methods of treating or preventing diseases using crystalline forms or pharmaceutical compositions.

Claims (12)

1. A crystalline form of 7-(3-(4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinazolin-7-yloxy)propyl)-2-oxa-7-azaspiro[3.5]nonane, wherein the crystalline form is crystalline form A having an X-ray powder diffraction (XRPD) pattern with peaks at about 6.11±0.3, 9.63±0.3, 9.87±0.3, 11.10±0.3, 11.46±0.3, 12.26±0.3, 12.88±0.3, 14.40±0.3, 15.45±0.3, 15.66±0.3, 16.41±0.3, 17.54±0.3, 18.16±0.3, 18.60±0.3, 19.51±0.3, 20.36±0.3, 21.12±0.3, 21.14±0.3, 22.31±0.3, 23.01±0.3, 24.79±0.3, 25.71±0.3, 26.84±0.3, and 28.90±0.3 degrees two theta.

2. The crystalline form of claim 1 having substantially the same XRPD pattern as shown in FIG. 1 .

3. A crystalline form of 7-(3-(4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinazolin-7-yloxy)propyl)-2-oxa-7-azaspiro[3.5]nonane, wherein the crystalline Form is crystalline Form B having an XRPD pattern with peaks at about 7.70±0.3, 13.53±0.3, 9.87±0.3, 10.69±0.3, 12.88±0.3, 14.40±0.3, 15.45±0.3, 16.42±0.3, 17.27±0.3, 18.44±0.3, 18.90±0.3, 19.73±0.3, 21.14±0.3, 22.56±0.3, 23.10±0.3, 26.07±0.3, 26.84±0.3, and 29.12±0.3 degrees two theta.

4. The crystalline form of claim 3 having substantially the same XRPD pattern as shown in FIG. 2 .

5. A pharmaceutical composition comprising the crystalline form of either of claim 1 or 3 and a pharmaceutically acceptable carrier or excipient.

6. A method of treating an ocular disease comprising administering an effective amount of the pharmaceutical composition of claim 5 to a subject in need thereof.

7. The method of claim 6 , wherein the pharmaceutical composition is administered topically, by injection, to the eye, orally, or by inhalation.

8. The method of claim 6 , wherein the ocular disease is retinopathy.

9. The method of claim 6 , wherein the ocular disease is age-related macular degeneration.

10. The method of claim 6 , wherein the ocular disease is corneal neovascularization.

11. The method of claim 6 , wherein the ocular disease is diabetic macular edema.

12. The method of claim 6 , wherein the ocular disease is retinal vein occlusion.

Assignments (4)
CHANGE OF NAME Recorded Sep 21, 2023
From: KALA PHARMACEUTICALS, INC.
To: KALA BIO, INC.
Reel/Frame 065017/0488 →
FIRST AMENDMENT TO IP SECURITY AGREEMENT Recorded Dec 22, 2022
From: KALA PHARMACEUTICALS, INC.
To: OXFORD FINANCE LLC
Reel/Frame 062205/0883 →
SECURITY INTEREST Recorded May 6, 2021
From: KALA PHARMACEUTICALS, INC.
To: OXFORD FINANCE LLC
Reel/Frame 056168/0602 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 2, 2020
From: ENLOW, ELIZABETH; NGUYEN, MINH NGOC; ONG, WINSTON Z.
To: KALA PHARMACEUTICALS, INC.
Reel/Frame 051983/0649 →
Continuity (8)
Continuation 16184760 · Nov 8, 2018
Continuation 15712645 · Sep 22, 2017
Continuation 14981105 · Dec 28, 2015
Division 14530092 · Oct 31, 2014
Provisional Application 62039177 · Aug 19, 2014
Provisional Application 62039192 · Aug 19, 2014
Provisional Application 61898741 · Nov 1, 2013
Related Publication 20200216459A1 · Jul 9, 2020