R41AG080914

Small molecule therapeutic for Alzheimer's disease - An estimated one out of eight individuals over the age of 65 has Alzheimer’s disease (AD), with a prevalence of 1-in-3 for those over age 85.

There are approximately 5.8 million people in the USA with AD, with a global projection of over 150 million by 2050. There remains a lack of effective treatment to halt disease progression.

Somatostatin receptor-4 (SSTR4) represents an innovative and viable brain target for AD treatment. A SSTR4 agonist has the potential to mitigate AD pathology via downstream enhancement of amyloid-beta metabolism, as well as the capacity to directly enhance cognitive function.

This program seeks to advance a first-in-class SSTR4 agonist drug for AD treatment. The goal of this Phase-I STTR is to establish an advanced lead SSTR4 agonist with optimized physiochemical attributes for enhancement of brain uptake.

An optimization process based on SSTR4 structure-activity relationships has been undertaken. The approach is iterative and as such each step informs the next with the data used to determine "go/no-go" advancement.

Compound design and screening includes state of the art computer-aided drug design, with synthesized compounds screened against through an iterative process.

A successful candidate from this Phase-I study will advance to the development phase, with GMP manufacturing of single candidate, full IND-enabling evaluations, and formulation for clinical trials. The IND preparation and FDA submission will precede clinical trials.

This program demonstrates a clear intellectual property pathway for commercialization. The goal and aims of this study address priorities of National Institutes of Health, specific to PAR-19-317.

Somatolynk

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Missouri United States

State-Wide

Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional) (PAS-19-317)

Amendment Since initial award the End Date has been extended from 07/31/24 to 07/31/25 and the total obligations have decreased 2% from $499,592 to $492,028.