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BEACH: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage Phase 2a Trial

Award Number: R01AG069930
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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BEACH: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage Phase 2a Trial - PROJECT SUMMARY 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,244,043 )
2025	2025	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	000	5	3/4/2025	NON-COMPETING CONTINUATION	$1,244,043
2025	2025	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	001	5	4/8/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,244,043

Issue Date FY: 2024 ( Subtotal = $2,140,865 )
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	001	4	5/13/2024	NON-COMPETING CONTINUATION	$214,086
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	000	4	12/8/2023	NON-COMPETING CONTINUATION	$1,926,779
														Subtotal = $2,140,865

Issue Date FY: 2023 ( Subtotal = $1,941,017 )
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	000	3	1/18/2023	NON-COMPETING CONTINUATION	$1,941,017
														Subtotal = $1,941,017

Issue Date FY: 2022 ( Subtotal = $1,966,656 )
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	000	2	1/6/2022	NON-COMPETING CONTINUATION	$1,769,990
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	002	2	4/22/2022	NON-COMPETING CONTINUATION	$196,666
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	001	2	1/25/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,966,656

Issue Date FY: 2021 ( Subtotal = $2,078,174 )
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Aging Research	000	1	2/11/2021	NEW	$2,078,174
														Subtotal = $2,078,174

Grand Total All Awards = $9,370,755

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BEACH: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage Phase 2a Trial

Award Number: R01AG069930

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/15/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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