Project Grant R01FD003902

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. The $999,615 award to Extend Biosciences Inc., a woman-owned small business, will fund a Phase 2 clinical trial to evaluate the safety, tolerability, and efficacy of...

This federal Project Grant award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) under the Arthritis, Musculoskeletal and Skin Diseases Research program (CFDA 93.846) provides $1,175,680.00 to The General Hospital Corporation (d.b.a. Massachusetts General Hospital) to conduct research comparing the therapeutic potential of combined anabolic therapy versus standard single-drug treatment in postmenopausal women at high risk of fragility fractures from...

The National Institute of Child Health and Human Development (NICHD) awarded a $1,857,842 Project Grant under the Child Health and Human Development Extramural Research program (CFDA 93.865) to The General Hospital Corporation, doing business as Massachusetts General Hospital (MGH), to conduct a 12-month randomized controlled trial. The grant will evaluate the use of the drug romosozumab, combined with estrogen replacement therapy and calcium/vitamin D supplementation, to improve bone mineral...

This federal Project Grant award from the National Institute on Aging (CFDA 93.866 - Aging Research) provides $298,883 to Iaterion, Inc. to develop a safer menopausal hormone therapy (MHT) formula that can be used long-term to treat protracted menopausal symptoms and prevent chronic diseases like osteoporosis, diabetes, obesity, and metabolic syndrome. The project aims to create an estradiol/reprogramming ligand combination that can potentially replace the progestin component of current MHT...

This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), will fund a $205,603 research project at Oregon Health & Science University (OHSU) from August 2024 to July 2027. The research aims to investigate the impact of estrogen replacement therapy on bone health in aging women living with HIV, who face increased risks of bone loss and fractures due to the combined effects of...

This U01FD008422 federal Cooperative Agreement award from the Food and Drug Administration (FDA) under the FDA Research program (CFDA 93.103) provides $250,000 in funding to The Regents of the University of California, San Francisco (UCSF) to support planning activities for the qualification of bone mineral density (BMD) as a surrogate biomarker for fracture risk in future osteoporosis clinical trials. The primary goal is to continue the FNIH-ASBMR-SABRE project's work with the FDA to formally...

This federal Project Grant award from the National Institutes of Health (NIH) Office of the Director under the Trans-NIH Research Support program (CFDA 93.310) provides $865,792 to the University of Massachusetts Lowell to study behavioral, lifestyle, and cultural risk factors for bone quality and osteoporosis in adults living in Puerto Rico. The key products and services to be delivered include: Quantifying bone mineral density and trabecular bone score in the ongoing PROSPECT cohort study to...

This Project Grant award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the Arthritis, Musculoskeletal and Skin Diseases Research program (CFDA 93.846), provides $465,663 to the Regents of the University of Michigan for research aimed at optimizing the bone surface targeting of therapeutic antibodies for the treatment of osteoporosis. The key objectives are to: 1) Optimize the pharmacokinetics and pharmacodynamics of an anti-sclerostin antibody in...

The National Institute of Child Health and Human Development (NICHD) awarded Madorra Inc., a woman-owned small business, a $1,514,498 SBIR Direct-to-Phase II Project Grant (CFDA 93.865) to develop an at-home, non-hormonal ultrasonic device for the treatment of vulvovaginal atrophy (VVA). VVA affects up to 90% of peri- and postmenopausal women, as well as many breast cancer survivors receiving estrogen-suppressing treatments. The project aims to 1) update the Madorra Therapy System design to...

This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $843,516 to Vanderbilt University Medical Center to conduct pharmacokinetic assessments of short-course rifapentine for tuberculosis (TB) preventive therapy in people living with HIV taking dolutegravir, children under 12 years, and pregnant women. The project aims to confirm that model-informed dosing of TB and HIV...