Granted Patent B2

US 12,201,639 · App. 17/809,192 · Granted Jan 21, 2025

Inventors: John Mccall (Boca Grande, FL); Jesse Damsker (Alexandria, VA)

Assignee: ReveraGen BioPharma, Inc.

A61K31/573A61K9/0053A61K9/08A61K47/10A61K47/36

Abstract

Claims (18)

1. A crystalline form of vamorolone characterized by one or more of the following:

an X-ray powder diffraction pattern comprising two or more peaks, in terms of ° 2θ, at about 11.9, about 13.7, about 16.1, and about 18.3 with radiation Cu Kα;

a thermogravimetric analysis profile showing less than about 0.5% weight loss below about 175° C.; and

an exothermic event onset at 180.7° C. and a melting event with an onset and peak temperatures of 231.0° C. and 234.7° C., respectively, as measured by differential scanning calorimetry; and

wherein the crystalline form has not more than 0.5% by high performance liquid chromatography of an impurity.

2. The crystalline form of vamorolone of claim 1 , wherein the impurity is

3. The crystalline form of vamorolone of claim 1 , wherein the impurity is

4. The crystalline form of vamorolone of claim 1 , wherein the impurity is

5. The crystalline form of vamorolone of claim 1 , wherein the impurity is

6. An oral pharmaceutical composition comprising the crystalline form of vamorolone of claim 1 .

7. The oral pharmaceutical composition of claim 6 , wherein the oral pharmaceutical composition is stable at 25° C./60% relative humidity for at least three months.

8. The oral pharmaceutical composition of claim 7 , wherein the oral pharmaceutical composition is stable at 25° C./60% relative humidity for at least one year.

9. A method of treating or reducing the symptoms of muscular dystrophy, comprising the administration, to a patient in need thereof, of a therapeutically effective amount of the crystalline form of vamorolone of claim 1 .

10. The method of claim 9 , wherein the muscular dystrophy is chosen from Duchenne muscular dystrophy, Becker muscular dystrophy, limb girdle muscular dystrophy, congenital muscular dystrophy, facioscapulohumeral muscular dystrophy, myotonic muscular dystrophy, oculopharyngeal muscular dystrophy, distal muscular dystrophy, and Emery-Dreifuss muscular dystrophy.

11. The method of claim 9 , wherein the muscular dystrophy is Duchenne muscular dystrophy.

12. The method of claim 9 , wherein the therapeutically effective amount is between 10 mg to 200 mg.

13. The method of claim 9 , wherein the therapeutically effective amount is between 0.01 mg/kg to 10.0 mg/kg.

14. The method of claim 9 , wherein the therapeutically effective amount is between 2 mg/kg to 6.0 mg/kg.

Assignments (1)

Continuity (4)

References Cited (376)