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GMP Production and Extended Toxicology of an Oral Formulation Drug for Alzheimer's Disease

Award Number: U01AG076480
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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GMP Production and Extended Toxicology of an Oral Formulation Drug for Alzheimer's Disease - ABSTRACT Alzheimer’s disease (AD) and related dementias are a major global public health problem, predicted to increase dramatically over the next decades. Effective therapies to prevent, cure, or slow the disease progression are lacking. A diversified portfolio of new therapeutic strategies with discrete pharmacological function is urgently needed. We propose repositioning of an existing acute brain injury clinical candidate, MW189, now in phase 2 critical care medicine testing for hemorrhagic stroke. Repositioning of therapeutic candidates in clinical development, or repurposing of approved drugs, are generally considered faster and more efficient approaches than de novo CNS drug discovery and development. Caveats include the lower success rates when done across disease indications (e.g., oncology to neurology) vs within the same disease indication. Repositioning of MW189 will use an existing CNS drug development portfolio and research infrastructure. Deliverables will allow rapid transition to clinical evaluation in AD patients. MW189 is a CNS-penetrant, small molecule that selectively attenuates stressor-induced changes in dysregulated cytokine production. The resultant pathophysiology contributes to synaptic dysfunction, neurodegeneration and cognitive decline in diverse diseases. MW189 has no liabilities in IND-enabling preclinical safety pharmacology and toxicology and successfully completed three phase 1 clinical studies of safety, tolerability, pharmacokinetics and pharmacodynamic end point engagement. MW189’s excellent profile in FDA guided preclinical and clinical studies provides a strong foundation for continued MW189 clinical development in other CNS disease areas. We hypothesize that MW189 is a viable candidate for daily oral treatment of dementia patients. We propose studies to remove the remaining technical and regulatory barriers to MW189 entry into future AD clinical investigations. Aim 1: Produce GMP clinical drug substance, drug product, reference standard and internal standard. GMP clinical drug for oral administration will be FDA quality compliant for phase 2 INDs and will address recent FDA new guidances on enhanced drug quality. Aim 2: Perform extended GLP toxicology studies in rats (6 mo) and dogs (9 mo) with recovery phase and toxicokinetics. Outcomes will allow future daily oral administration to AD patients and provide refined dosing parameters for longer term administration. Aim 3: Obtain a phase 2 IND for future clinical trials in early AD and related dementias. This final milestone will position us to immediately proceed to a future phase 2a clinical study of AD patients. Successful outcomes from the proposed investigations and the follow-on clinical trials will impact a number of CNS disorders where cytokine dysregulation is part of the disease progression or susceptibility mechanism.


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: 2026 ( Subtotal = $0 )
2026	2025	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Aging Research	000	4	12/9/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $815,581 )
2025	2025	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Aging Research	000	4	7/4/2025	NON-COMPETING CONTINUATION	$815,581
														Subtotal = $815,581

Issue Date FY: 2024 ( Subtotal = $2,917,299 )
2024	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Aging Research	001	3	6/6/2024	SUPPLEMENT FOR EXPANSION	$1,370,663
2024	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Aging Research	000	3	5/23/2024	NON-COMPETING CONTINUATION	$1,546,636
														Subtotal = $2,917,299

Issue Date FY: 2023 ( Subtotal = $1,547,324 )
2023	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Aging Research	001	2	6/12/2023	NON-COMPETING CONTINUATION	$1,547,324
2023	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Aging Research	000	1	6/9/2023	NEW	$0
														Subtotal = $1,547,324

Issue Date FY: 2022 ( Subtotal = $1,546,977 )
2022	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Aging Research	000	1	5/19/2022	NEW	$1,546,977
														Subtotal = $1,546,977

Grand Total All Awards = $6,827,181

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GMP Production and Extended Toxicology of an Oral Formulation Drug for Alzheimer's Disease

Award Number: U01AG076480

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 06/01/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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