Aminosterol compositions and methods of using the same for treating schizophrenia
Inventors
Barbut, Denise • Zasloff, Michael
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11464789-B2
Publication Date
2022-10-11
Expiration Date
Abstract
The present application relates generally to methods for treating, preventing and/or slowing the onset or progression of schizophrenia and/or a related symptom. The methods comprise administering at least one aminosterol or a pharmaceutically acceptable salt or derivative thereof to a subject in need.
Core Innovation
The invention relates to aminosterol-based compositions and methods of ameliorating the progression of schizophrenia (SZ) in a subject in need by administering a therapeutically effective amount of at least one aminosterol or a salt thereof. The aminosterol comprises squalamine or a pharmaceutically acceptable salt thereof and/or a squalamine phosphate salt, and/or aminosterol 1436 or a pharmaceutically acceptable salt thereof, and/or an aminosterol 1436 phosphate salt. The method is measured by amelioration of a symptom of SZ.
The invention further includes determining a therapeutically effective amount by identifying a SZ symptom to be evaluated, identifying a starting dose for the subject, and administering an escalating dose over a first defined period of time until the therapeutically effective amount for that SZ symptom is identified. The therapeutically effective amount is the aminosterol dose where improvement or resolution of the SZ symptom is observed, and the aminosterol dose is then fixed at the therapeutically effective amount for that particular SZ symptom in that particular subject.
The disclosed approach is described in the context of schizophrenia-associated constipation and related bowel measures, including spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM), with stool metrics such as Bristol stool consistency and ease of passage. It also describes CNS symptoms, brain-gut related symptoms, and exploratory clinical-trial observations including constipation, hallucinations, REM-behavior disorder, circadian rhythm/sleep, cognitive impairment, and depression.
Claims Coverage
Two independent claims are provided. They share a core method for ameliorating SZ progression using aminosterols, including squalamine and aminosterol 1436 salts, and differ in how the therapeutically effective amount is determined.
Aminosterol-based method to ameliorate schizophrenia progression
Administering to a subject diagnosed with schizophrenia (SZ) a therapeutically effective amount of at least one aminosterol or a salt thereof, wherein the aminosterol comprises squalamine and/or a squalamine phosphate salt and/or aminosterol 1436 and/or an aminosterol 1436 phosphate salt, wherein progression is ameliorated as measured by amelioration of a symptom of SZ.
Escalating-dose determination and fixed aminosterol dose
Identifying a SZ symptom, identifying a starting dose, administering an escalating dose over a first defined period until improvement or resolution of the SZ symptom is observed, and fixing the aminosterol dose at the therapeutically effective amount for that particular SZ symptom in that particular subject.
The independent claims focus on administering aminosterols to ameliorate schizophrenia progression through symptom improvement, and on selecting a therapeutically effective dose through an escalating-dose procedure targeted to a chosen SZ symptom, followed by fixing the dose for that subject and symptom.
Stated Advantages
Amelioration of the progression of schizophrenia (SZ) as measured by amelioration of a symptom of SZ.
Improvement or resolution of the SZ symptom used to determine the therapeutically effective amount, followed by fixing the dose at that therapeutically effective amount for that particular SZ symptom in that particular subject.
Reduced rescue medication and changes in CNS symptoms during washout are described in the provided content.
Documented Applications
Treatment of schizophrenia-related symptoms in a subject diagnosed with SZ using aminosterol or a salt thereof.
Treatment of schizophrenia-associated constipation and related bowel measures, including SBM and CSBM, with stool metrics such as Bristol stool consistency and ease of passage.
Schizophrenia symptom targeting and evaluation using a selected SZ symptom and clinical scales and/or imaging techniques to assess progression and response.
Interested in licensing this patent?