US 12,329,726 B2
Biomarkers for efficacy of prophylactic treatments against stress-induced affective disorders
Josephine Cecelia McGowan, New York, NY (US); Christine Ann Denny, Ho-Ho-Kus, NJ (US); and Michael Kiebish, Framingham, MA (US)
Assigned to The Trustees of Columbia University in the City of New York, New York, NY (US); BPG BIO, INC, Framingham, MA (US); and The Research Foundation for Mental Hygiene, Inc, Menands, NY (US)
Filed by The Trustees of Columbia University in the City of New York, New York, NY (US); BPG BIO, INC., Framingham, MA (US); and The Research Foundation for Mental Hygiene, Inc., Menands, NY (US)
Filed on Sep. 28, 2022, as Appl. No. 17/954,858.
Application 17/954,858 is a continuation of application No. 16/761,548, granted, now 11,622,948, previously published as PCT/US2018/059834, filed on Nov. 8, 2018.
Claims priority of provisional application 62/583,734, filed on Nov. 9, 2017.
Prior Publication US 2023/0285322 A1, Sep. 14, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/135 (2006.01); A61K 9/00 (2006.01); A61P 25/22 (2006.01); A61P 25/24 (2006.01)
CPC A61K 31/135 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0043 (2013.01); A61K 9/0053 (2013.01); A61P 25/22 (2018.01); A61P 25/24 (2018.01); G01N 2800/30 (2013.01); G01N 2800/52 (2013.01)] 19 Claims
 
1. A method for treating a subject for a stress-induced affective disorder or stress-induced psychopathology, the method comprising:
(a) 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;
(b) determining level of one or more biomarkers in a biological sample obtained from the subject after step (a) and after the stressor, wherein the one or more biomarkers are selected from the 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, and 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; and
(c) comparing the level obtained in step (b) with the level of the one or more biomarkers in a control sample,
wherein the stress-induced affective disorder or stress-induced psychopathology is selected from the group consisting of: 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.