Abstract: Disclosed herein are forms of L-ornithine phenyl acetate and methods of making the same. A crystalline form may, in some embodiments, be Forms I, II, III and V, or mixtures thereof. The crystalline forms may be formulated for treating subjects with liver disorders, such as hepatic encephalopathy. Accordingly, some embodiments include formulations and methods of administering L-ornithine phenyl acetate.
Type:
Grant
Filed:
November 1, 2021
Date of Patent:
January 6, 2026
Assignee:
Amalive Limited
Inventors:
Keith Anderson, Jim Behling, Christine Henderson Dougan, Stephen William Watt, Peter Manini, Attilia Figini
Abstract: The present disclosure relates to methods of treating or ameliorating hepatic encephalopathy (HE), including assessing the severity of HE in a patient suffering from HE, or the determining the presence or occurrence of an overt hepatic encephalopathy event. In particular, some aspects of the methods use a novel Hepatic Encephalopathy Staging Tool (HEST), which includes a set of criteria to categorize the HE into different stages and provide guidance on effective treatments based on the severity of the HE. Other aspects of the methods use an Overt Hepatic Encephalopathy Screening Tool (O-HEST) to determine whether an OHE event is occurring or has occurred and provide guidance on proper medical attention and change in treatment.