Biomarkers for efficacy of prophylactic treatments against stress-induced affective disorders
Inventors
MCGOWAN, Josephine Cecelia • DENNY, Christine Ann • KIEBISH, Michael
Assignees
Bpg Bio Inc • Columbia University in the City of New York • Research Foundation for Mental Hygiene Inc
Publication Number
US-12329726-B2
Publication Date
2025-06-17
Expiration Date
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Abstract
Biomarkers for assessing the efficacy of prophylactic treatments of stress-induced affective disorders are provided.
Core Innovation
The present disclosure provides for a method for treating a subject for a stress-induced affective disorder or stress-induced psychopathology comprising: (a) administering or having administered a prophylactic treatment to the subject prior to a stressor; (b) determining the level of one or more biomarkers in a biological sample obtained from the subject after step (a) and after the stressor; and (c) comparing the level obtained in step (b) with the level of the one or more biomarkers in a control sample. The disclosure also provides for a method for assessing a prophylactic treatment comprising determining the level of one or more biomarkers in a biological sample obtained from the subject after a prophylactic treatment and after a stressor and comparing that level with a control sample.
The background describes that stress is a common risk factor for psychiatric disorders such as major depressive disorder (MDD) and posttraumatic stress disorder (PTSD), and that there is currently no method to predict which patients are likely to benefit from prophylactic pharmacological interventions. The disclosure addresses the need for biomarkers and therapeutic targets to develop prophylactic treatments against stress-induced psychiatric disorders and for blood tests to predict patient responsiveness to such treatments.
Claims Coverage
The independent claim recites a method with five main inventive features.
Prophylactic administration of ketamine
Administering or having administered a prophylactic treatment to the subject prior to a stressor, wherein the prophylactic treatment comprises an effective amount of a pharmaceutic composition comprising ketamine or a pharmaceutically acceptable salt thereof.
Post-treatment biomarker measurement
Determining the level of one or more biomarkers in a biological sample obtained from the subject after the prophylactic treatment and after the stressor.
Comparison to a control sample
Comparing the determined biomarker level with the level of the one or more biomarkers in a control sample.
Specific biomarker panel
Use of biomarkers selected from a group consisting of adenine, adenosine monophosphate (AMP), adenosine triphosphate (ATP), D-ribose 5-phosphate, D-ribulose 5-phosphate, guanosine monophosphate, guanosine diphosphate, hypoxanthine, inosine, phosphoribosyl pyrophosphate, dihydrothymine, uridine 5‑monophosphate, uridine‑diphosphate, 5,6‑dihydrouridine, serine, glutamic acid, gamma-aminobuytric acid (GABA), 5‑hydroxy‑L‑tryptophan (5‑HTP), O‑phosphoethanolamine (PE), N‑acetyl‑L‑tyrosine, and combinations thereof.
Therapeutic target indications
Application of the method for treating or assessing prophylactic treatment of stress-induced affective disorders and stress-induced psychopathology selected from depressive-like behavior and associated affective disorders, anhedonic behavior and associated affective disorders, anxiety and associated affective disorders, cognitive impairments and deficits and associated disorders, and combinations thereof.
The independent claim covers prophylactic administration of a ketamine-containing composition prior to a stressor, measuring specified purine, pyrimidine and neurotransmitter-related biomarkers in a biological sample after treatment and stress, comparing those levels to a control sample, and applying the results to treat or assess a range of stress-induced affective disorders.
Stated Advantages
Biomarkers can be used to develop targeted prophylactic treatments and blood tests to predict patient responsiveness to treatments for informed treatment decisions.
The biomarkers may be used for drug discovery to identify new targets for prophylactic treatments against stress-induced psychiatric disorders.
The biomarkers may help identify individuals at risk of developing stress-related psychiatric disorders and may be used for a diagnostic test to discriminate between different etiologies of a psychiatric disease.
The biomarkers may enable identification of individuals who would be responsive to a prophylactic treatment against a stress-induced affective disorder, addressing the unmet need that up to 30% of depression patients do not respond to pharmacological treatment.
Documented Applications
A method for treating a subject for a stress-induced affective disorder or stress-induced psychopathology using prophylactic administration of ketamine or related compositions prior to a stressor.
A method for assessing a prophylactic treatment by determining biomarker levels in biological samples after prophylactic treatment and after a stressor and comparing to a control sample.
Use of biomarker-based blood tests to predict patient responsiveness to prophylactic treatments and to inform treatment decisions.
Use of the biomarkers in drug discovery to identify new targets for prophylactic treatments against stress-induced psychiatric disorders.
Use of biomarkers to identify individuals at risk of developing stress-related psychiatric disorders and to provide diagnostic tests to discriminate between different etiologies.
Kits containing reagents and instructions for measuring at least one biomarker in a biological sample and for evaluating or monitoring therapeutic efficacy of a prophylactic treatment based on biomarker levels.
Prophylactic administration of the disclosed agents prior to anticipated traumatic exposures for populations such as military personnel and first responders to protect against stress.
Assessing or predicting the severity or progression of the disorder/condition in a subject by measuring biomarker levels and comparing to reference or control levels.
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