Beach: biomarker and edema attenuation in intracerebral hemorrhage phase 2A trial
Active Project Grant Awarded Last action
- Award ID
- R01AG069930
- Recipient
-
The Johns Hopkins University UEI FTMTDMBR29C7
- Awarding agency
-
National Institute on Aging
National Institutes of Health, Department of Health and Human Services
- Obligated
- $31,675,276
Award facts
- Assistance listing
- 93.866 Aging Research
- Completion date 98% complete
- Originally
- Funding
-
- $29,597,102.00 Federal
- $2,078,174.00 Non-federal
- Place of performance
- Maryland, USA
Award details come from USAspending.gov.
Description
- Abstract
- Acute brain injuries resulting from cerebrovascular injury or trauma, such as intracerebral hemorrhage (ICH) or traumatic brain injury, are major medical problems that cause considerable mortality and morbidity in older americans. Secondary neuroinflammatory events after ICH can further damage the brain and lead to increased risk of neurologic complications including alzheimer's disease (ad) and related dementias. Despite significant advances in the medical management of these patients, there is a clear and urgent need for interventions that improve neurologic recovery and outcomes. To address this unmet need, the clinical candidate, MW189, is a CNS-penetrant, small molecule that selectively attenuates injury- and disease-induced proinflammatory cytokine overproduction. Proinflammatory cytokine overproduction from abnormally activated glia contributes to cerebral edema, long-term neurological damage, and cognitive deficits following acute brain injuries. This mechanistic linkage of the acute cytokine surge to progression of injury, plus the attractive therapeutic time window of hours to days post-insult, provide a rational therapeutic target for intervention in the acute care setting. The biomarker and edema attenuation in intracerebral hemorrhage (beach) trial is a first-in-patient phase 2A, proof-of-concept study of MW189 in patients with ICH. The study aims are to: (1) prepare, recruit, and conduct the phase 2A clinical study of MW189, and (2) evaluate safety, pharmacokinetics (PK), inflammatory biomarkers, and clinical outcomes. This multicenter, prospective, randomized, double-blind controlled trial will enroll 120 non-traumatic ICH participants, with an anticipated average age in their mid-60S and substantial numbers of individuals with cerebral small vessel disease and cerebral amyloid angiopathy. Patients will be randomized to MW189 or placebo in a 1:1 ratio, with the first dose initiated within 24 hours of symptoms, then dosing every 12 hours for 5 days (or until discharge, whichever is first). Safety and tolerability of MW189 compared to placebo, and PK profiles of MW189 will be determined. Exploratory outcomes will include radiographic and clinical endpoints and measurement of plasma levels of brain-derived inflammatory and neuronal injury biomarkers to demonstrate engagement of pharmacological mechanism. Success with MW189 in ICH patients will further DE-risk the compound for subsequent larger trials of acute CNS injury and/or to develop the drug for ad and other age-related dementias. The study will also generate important information about the utility of targeting the acute proinflammatory cytokine aspects of neuroinflammation in older americans with vascular disease.
Transactions
| Action | Federal | Non-federal | Date |
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| Amendment | $1,769,990 | $0 | |
| Amendment | $1,769,990 | $0 | |
| Amendment | $2,078,174 | $0 | |
| Original award | $2,078,174 | $2,078,174 |
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Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Yale Univ | $57,025 | |
| The University Of Kentucky Research Foundation | $1,887,067 | |
| Cincinnati Univ Of | $105,595 | |
| Yale Univ | $283,165 | |
| Subrecipient not on record | $149,361 | |
| The Leland Stanford Junior University | $114,031 | |
| The University Of Texas Health Science Center At San Antonio | $114,932 | |
| University Of Kentucky | $173,416 | |
| University Of New Mexico | $68,686 | |
| University Of Alabama At Birmingham | $69,324 | |
| University Of Texas Health Science Center At Houston | $103,580 | |
| The Cleveland Clinic Foundation | $170,562 | |
| New York University | $69,517 | |
| Yale Univ | $82,079 | |
| The Cleveland Clinic Foundation | $51,770 | |
| The Medical University Of South Carolina | $41,674 |
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Quick answers
Who received award R01AG069930?
R01AG069930 was awarded to The Johns Hopkins University by National Institute on Aging (National Institutes of Health) on February 15, 2021.
How much is award R01AG069930 worth?
$31,675,276 has been obligated on R01AG069930: $29,597,102 in federal funding and $2,078,174 in non-federal funding.
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