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Lead Optimization of a Therapeutic Candidate for Alzheimer’s Disease

Award Number: R43AG090243
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2025
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Lead Optimization of a Therapeutic Candidate for Alzheimer’s Disease - Summary. Overactivation of the hypothalamic-pituitary-adrenal (HPA) axis occurs in Alzheimer's disease (AD) and dysregulation of the stress system plays a mechanistic role in the pathophysiology of AD progression. This Phase I SBIR proposal will set the groundwork for the clinical development of a first-in-class treatment for the long-term management for AD and other conditions characterized by excessive activation of the HPA. While the stress response is essential for survival, it can become dysregulated. Excessive activation of the HPA axis results in increased glucocorticoids release, which has detrimental actions on the central nervous system, causing hippocampal and prefrontal cortex functional impairments, and contributes to AD progression. Therapeutics to modulate the HPA axis have been under research for decades. While glucocorticoid receptor antagonists have shown some potential in the treatment of depression, they can be counterproductive when used long-term. CRF receptor type 1 (CRF1) antagonists have also been studied extensively but have generally been unsatisfactory due to side effects and limited efficacy on the HPA. Brain-penetrant CRF1 antagonists can induce fear and aversion in humans, which may represent class side effects. Thus, there is a considerable unmet medical need for identification of novel therapeutics to normalize HPA hyperactivity that are effective and tolerable for long-term use. HPA hyperactivity is believed to be a key pathogenic driver of AD and a validated therapeutic target. The present Phase I SBIR seeks to advance the development of a novel therapeutic to reduce HPA hyperactivity and will lay the foundations for the clinical development of a first-in-class therapeutic by optimizing a lead candidate therapeutic for the long-term management of chronic hyperactivity of the hypothalamic pituitary adrenal axis (HPA) for AD and other degenerative conditions.


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 = $349,605 )
2025	2025	STRESS THERAPEUTICS, INC.	3443 WHITTIER ST	SAN DIEGO	CA	92106	SAN DIEGO	USA	Aging Research	000	1	5/30/2025	NEW	$349,605
														Subtotal = $349,605

Grand Total All Awards = $349,605

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Lead Optimization of a Therapeutic Candidate for Alzheimer’s Disease

Award Number: R43AG090243

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2025

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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