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`2017-08-14
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`PTO/AIA/14 (11-15)
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`Attorney Docket Number|50535-709.101
`Application Data Sheet 37 CFR 1.76
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`This collection of information is required by 3 CFR 1.76. The information is required to obtain or retain a benefit by the public which
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`WSGRDocket No. [50535-709.101]
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`PATENT APPLICATION
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`CORTICOTROPIN RELEASING FACTOR RECEPTOR ANTAGONISTS
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`Inventor(s): Alexis HOWERTON
`548 Market Street, Suite 74589
`San Francisco, California 94105
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`Hal GERBER,
`548 Markct Street, Suite 74589
`San Francisco. California 94105
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`Assignee:
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`Spruce Biosciences, Inc.
`548 Market Street, Suite 74589
`San Francisco, California 94105
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`Entity:
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`Large business concern
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`We3R
`Wilson Sonsini Goodrich & Rosati
`PROFESSIONAL CORPORATION
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`650 Page Mill Road
`Palo Alto, CA 94304
`(650) 493-9300 (Main)
`(650) 493-6811 (Facsimile)
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`Filed Electronically on: August 14, 2017
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`WSGRDocket No. 50535-709.101
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`CORTICOTROPIN RELEASING FACTOR RECEPTOR ANTAGONISTS
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`BACKGROUNDOF THE INVENTION
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`[0001] Corticotropin releasing factor (CRF) is a 41 amino acid peptide that is the primary
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`physiological regulator of proopiomelanocortin (POMC) derived peptide secretion from the anterior
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`pituitary gland. In addition to its endocrine role at the pituitary gland, immunohistochemical
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`localization of CRF has demonstrated that the hormonchas a broad extrahypothalamic distribution
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`in the central nervous system and produces a wide spectrum of autonomic, electrophysiological and
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`behavioral effects consistent with a neurotransmitter or neuromodulator role in the brain. There is
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`also evidence that CRF plays a significant role in integrating the response in the immune systemto
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`physiological, psychological, and immunologicalstressors.
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`SUMMARYOF THE INVENTION
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`[0002] The present invention provides novel pharmaceutical composilions comprising 4-(4-chloro-
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`5-(2,5-dimethy1-7-(pentan-3- yl)pyrazolo[1,5-a]pyrimidin-3-yl)thiazol-2-yl)morpholine and methods
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`using such pharmaceutical compositions for treating congenital adrenal hyperplasia (CAH).
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`[0003] Disclosed herein is method oftreating congenital adrenal hyperplasia (CAH) in a subject in
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`need thereof, comprising administcring a pharmaccutical composition comprising Compound1:
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`“A n-N
` =
`N NN
`Oo.?
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`or a pharmaceutically acceptable salt or solvate thereof, wherein Compound 1
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`is administered at a
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`dose between about 200 mg/day and about 1600 mg/day.
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`[0004] In some embodiments, Compound 1, or a pharmaceutically acceptable salt or solvate thereof,
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`is administered at a dose between about 200 mg/day and about 1200 mg/day. In some embodiments,
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`Compound1, or a pharmaceutically acceptable salt or solvate thereof, is administered at a dose
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`between about 200 mg/day and about 1000 mg/day. In som