Cooperative Agreement W81XWH1820059

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 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 4-week open-label study will enroll 20 patients with de novo, persistent, or recurrent Cushing's disease and assess fimepinostat's ability to normalize or...

This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $541,080 to The Trustees of Columbia University in the City of New York to conduct a human laboratory study examining the effects of repeated cannabidiol (CBD) administration on the abuse-related and analgesic effects of smoked cannabis. The key objectives of this 5-year study are to determine whether daily oral CBD administration alters: 1) the...

This Cooperative Agreement award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research program (CFDA 93.837), provides $742,984 to the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University to conduct a 3-center, double-blind, placebo-controlled, randomized Phase II clinical trial testing whether the drug empagliflozin can improve heart function and other outcomes in patients with pulmonary arterial hypertension. The...

This Project Grant award from the National Institute on Aging's Aging Research Federal Grant Program (CFDA 93.866) will support the conduct of a randomized, placebo-controlled, Phase 2 platform trial evaluating the safety, tolerability, and clinical proof-of-concept of at least three different tau-related or neuroprotective therapies for the treatment of mild-to-moderate Progressive Supranuclear Palsy (PSP). The award provides $15,782,145 over 5 years and will leverage the expertise and...

This federal Project Grant award of $999,615.00 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. The award will fund a second clinical study in healthy volunteers to evaluate the safety and tolerability of multiple doses of EXT608, as well as...

This federal Project Grant award from the National Institute on Aging (CFDA 93.866 - Aging Research) provides $926,389 to Wake Forest University Health Sciences (WFUHS) to conduct a clinical PET imaging study using the radiotracer [11C]MPC-6827 to evaluate microtubule integrity as an early biomarker of Alzheimer's disease progression. The study will enroll 75 participants, including cognitively normal adults, cognitively normal adults with positive amyloid PET scans, and adults with mild...

This Project Grant award from the National Institute on Aging's Aging Research program (CFDA 93.866) provides $3,357,206 to Allyx Therapeutics Inc. to conduct clinical evaluation of the drug BMS-984923 for the treatment of Alzheimer's disease (AD). The project aims to develop a novel disease-modifying compound that targets the underlying mechanism of synapse loss, a key driver of cognitive decline in AD. Preliminary studies have demonstrated the drug's efficacy in preclinical mouse models, where...

This $426,250 Project Grant awarded by the National Institute on Aging (under CFDA 93.866 - Aging Research) to Wake Forest University Health Sciences will fund the development and evaluation of a novel Positron Emission Tomography (PET) radiotracer, [11C]TM-N1324, to quantify in vivo levels of the G-protein coupled receptor GPR39 in rodent models and postmortem human brain tissues of Alzheimer's disease (AD). The project aims to establish the imaging utility of [11C]TM-N1324 in two rodent...

This Project Grant award from the National Institute on Aging (CFDA 93.866 Aging Research) provides $349,605 to Stress Therapeutics, Inc. to advance the development of a novel therapeutic candidate for the long-term management of Alzheimer's disease (AD) and other conditions characterized by excessive activation of the hypothalamic-pituitary-adrenal (HPA) axis. The goal is to optimize a lead compound and lay the groundwork for clinical development of a first-in-class treatment to normalize HPA...

The National Institute on Aging (NIA) awarded a $618,401 Cooperative Agreement (U01AG081450) to The University of Texas Southwestern Medical Center to conduct research on the pharmacokinetics (PK) and pharmacodynamics (PD) of mTOR inhibitors in older adults. The primary goal is to precisely estimate fundamental PK/PD parameters of sirolimus and everolimus in older adults without confounding illnesses. The research will involve validating measurement techniques, quantifying in vitro...