Tuesday, September 16, 2025 9/16/2025

Novel therapeutic for HPA hyperactivity

Award Number: R44AA027971
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Novel therapeutic for HPA hyperactivity - Summary. The hypothalamic pituitary adrenal (HPA) axis is the key neuroendocrine system that controls peripheral responses to stress. While the stress response is essential for survival, it can become dysregulated. Hyperactivity of the HPA characterizes a variety of illnesses including alcohol use disorder (AUD). HPA hyperactivity is characterized by higher production of corticotropin-releasing factor (CRF) and glucocorticoids. This Phase II SBIR aims to develop a novel biologic therapeutic aimed at normalizing pathologic HPA hyperactivity. Medications to modulate the HPA axis are currently sub-optimal. Therapeutic attempts to use glucocorticoid receptor (GR) antagonists have shown some promise in conditions like AUD and depression. However, chronically blocking GR-mediated effects can be counterproductive as, for instance, it interferes with glucocorticoid negative feedback, leading to increased cortisol levels and mineralocorticoid receptor activation. CRF receptor type 1 (CRF1) antagonists have been extensively explored, but thus far have proven disappointing, possibly because of the pharmacokinetics and pharmacodynamics properties of the existing drugs. Therefore, the identification of novel therapeutics to normalize hyperactivity of the HPA axis represents an area of significant unmet medical need. This proposal will optimize a lead validated in the Phase I SBIR and establish a stable cell line for the production of material for the eventual Investigational New Drug (IND)-enabling studies and clinical trials. Altogether, the present project will lay the foundations for the clinical development of a first-in-class therapeutic for AUD and potentially for other conditions characterized by HPA axis hyperactivity.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $716,742 )
2025	2025	STRESS THERAPEUTICS, INC.	3443 WHITTIER ST	SAN DIEGO	CA	92106	SAN DIEGO	USA	Alcohol Research Programs	000	4	7/17/2025	NON-COMPETING CONTINUATION	$716,742
														Subtotal = $716,742

Issue Date FY: 2024 ( Subtotal = $605,404 )
2024	2024	STRESS THERAPEUTICS, INC.	3443 WHITTIER ST	SAN DIEGO	CA	92106	SAN DIEGO	USA	Alcohol Research Programs	000	3	6/5/2024	NON-COMPETING CONTINUATION	$605,404
														Subtotal = $605,404

Issue Date FY: 2023 ( Subtotal = $605,405 )
2023	2023	STRESS THERAPEUTICS INC	3443 WHITTIER ST	SAN DIEGO	CA	92106	SAN DIEGO	USA	Alcohol Research Programs	000	2	4/28/2023	COMPETING CONTINUATION	$605,405
														Subtotal = $605,405

Grand Total All Awards = $1,927,551

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Novel therapeutic for HPA hyperactivity

Award Number: R44AA027971

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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