Project Grant R43AA027971

The U.S. National Institute on Aging (NIA) awarded a $349,605 Project Grant (CFDA 93.866) to Stress Therapeutics, Inc. to advance the development of a novel therapeutic candidate for the long-term management of chronic hyperactivity of the hypothalamic pituitary adrenal (HPA) axis, a key pathogenic driver of Alzheimer's disease and other degenerative conditions. The Phase I SBIR grant will fund lead optimization and lay the foundations for the clinical development of this first-in-class...

This Project Grant award from the Food and Drug Administration (FDA) Research program (CFDA 93.103) provides $849,648 to the University of California, Los Angeles (UCLA) to conduct a pilot Phase II clinical study evaluating the safety and efficacy of the dual PI3K and HDAC inhibitor drug fimepinostat for the treatment of Cushing's disease. The study aims to assess the ability of fimepinostat to normalize or reduce 24-hour urinary free cortisol levels in 20 patients with de novo, persistent, or...

This Project Grant award of $1,325,500 from the National Institute of Neurological Disorders and Stroke (NINDS) under the Drug Use and Addiction Research Programs (CFDA 93.279) aims to develop novel PAC1 receptor antagonists for the treatment of medication overuse headache (MOH). The primary objectives are to: Utilize computational modeling and virtual screening to identify new PAC1 receptor antagonist molecules, as well as optimize the potency of an existing antagonist compound (PA8). This work...

This Cooperative Agreement award from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) under the Alcohol Research Programs (CFDA 93.273) provides $999,393 in funding to Stress Therapeutics, Inc. for IND-enabling studies of a novel therapeutic candidate to address alcohol use disorder (AUD). The goal is to advance the development of a first-in-class treatment for chronic management of pathological hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis, a key driver of AUD....

This Project Grant award from the National Institute on Aging (CFDA 93.866 - Aging Research) provides $560,636 to the Trustees of Indiana University, doing business as Indiana University Indianapolis, to investigate the potential therapeutic benefits of activating the HCAR2 receptor to mitigate tau pathology in preclinical models of tauopathies. The key objectives are to: 1) Establish an effective therapeutic strategy for treating tau pathology by activating the HCAR2 receptor using the...

Novelmed Therapeutics, Inc. was awarded a $900,000 Project Grant from the National Institutes of Health's National Institute on Aging to develop a selective inhibitor of the alternative pathway of complement as a treatment for Neuromyelitis Optica Spectrum Disorder. Under the grant, Novelmed will conduct preclinical studies to evaluate its lead drug candidate NM5072, including in vitro and ex vivo assays to confirm the drug's mechanism of action and selective inhibition of the alternative...

This Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), is funding the development of a novel therapeutic antibody for the treatment of acromegaly. Acromegaly is a rare endocrine disorder caused by excess growth hormone production that can lead to serious health complications. The $1,035,589 grant will enable the awardee, Elixera, Inc., to prepare...

This Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), supports the development of a long-acting parathyroid hormone (PTH) derivative, EXT608, for the treatment of hypoparathyroidism. Extend Biosciences Inc., a woman-owned small business, received $999,615 to conduct a second clinical study in healthy volunteers and begin a Phase 2 clinical trial to...

This $3.38 million project grant from the National Institutes of Health's National Institute on Aging will fund research to repurpose FDA-approved agonists of the HCAR2 receptor as novel therapeutics for Alzheimer's disease. The grantee, Indiana University Iupui, will conduct preclinical studies using the 5XFAD mouse model of Alzheimer's disease to evaluate the therapeutic efficacy and pharmacological targets of the FDA-approved drugs niaspan and dimethyl fumarate in modulating microglial...

This Project Grant award of $999,998.00 from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research Federal Grant Program (CFDA 93.837), supports the development of a novel long-acting conjugate of the vasodilative hormone, human brain natriuretic peptide (HBNP), to treat resistant hypertension. The awardee, Antlia Bioscience, Inc., will pursue the bulk manufacture of clinical-grade PAS(400)-HBNP, conduct dose-range-finding pharmacokinetic and...