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Last Updated: December 18, 2025

Claims for Patent: 12,344,585

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Summary for Patent: 12,344,585

Title:	Crystalline salts of a plasma kallikrein inhibitor
Abstract:	Disclosed are crystalline salts of Compound I, methods of preparing them, and related pharmaceutical preparations thereof. Also disclosed are methods of treatment using the crystalline salts of the invention.
Inventor(s):	Yahya El-Kattan, Yarlagadda S. Babu
Assignee:	Biocryst Pharmaceuticals Inc
Application Number:	US18/120,073
Patent Claims:	1. A method for prophylaxis to prevent attacks of hereditary angioedema, comprising orally administering once a day to a subject with hereditary angioedema from about 125 mg to about 175 mg of a crystalline salt of Compound I, wherein the crystalline salt is characterized by peaks in the X-ray powder diffraction (XRPD) pattern at values of two theta (°2θ±0.2°) of 5.3, 9.0, and 22.0; and the crystalline salt is a bis(hydrochloride) salt. 2. The method of claim 1, wherein about 125 mg of the crystalline salt of Compound I is administered to the subject. 3. The method of claim 1, wherein about 175 mg of the crystalline salt of Compound I is administered to the subject. 4. The method of claim 1, wherein the crystalline salt is characterized by peaks in the X-ray powder diffraction (XRPD) pattern at values of two theta (°2θ) of 5.3, 9.0, and 22.0. 5. The method of claim 1, wherein the crystalline salt is characterized by peaks in the X-ray powder diffraction (XRPD) pattern at values of two theta (°2θ±0.2°) of 5.3, 9.0, 19.8, 21.2, 22.0, and 23.3. 6. The method of claim 5, wherein the crystalline salt is characterized by peaks in the X-ray powder diffraction (XRPD) pattern at values of two theta (°2θ) of 5.3, 9.0, 19.8, 21.2, 22.0, and 23.3. 7. The method of claim 1, wherein the crystalline salt is characterized by peaks in the X-ray powder diffraction (XRPD) pattern at values of two theta (°2θ±0.2°) of 5.3, 9.0, 14.3, 16.2, 19.8, 21.2, 22.0, 23.3, 24.6, and 30.3. 8. The method of claim 7, wherein the crystalline salt is characterized by peaks in the X-ray powder diffraction (XRPD) pattern at values of two theta (°2θ) of 5.3, 9.0, 14.3, 16.2, 19.8, 21.2, 22.0, 23.3, 24.6, and 30.3. 9. The method of claim 1, wherein the crystalline salt is characterized by an XRPD pattern substantially similar to that shown in FIG. 1 . 10. The method of claim 1, wherein the crystalline salt has a thermogravimetric-infrared spectrum substantially as shown in FIG. 2 . 11. The method of claim 1, wherein the hereditary angioedema is type I hereditary angioedema. 12. The method of claim 1, wherein the hereditary angioedema is type II hereditary angioedema.

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