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Formulation of a Novel Therapeutic for Treating Cognitive Impairment in Patients at-risk for Alzheimer's Disease-Related Dementias and Vascular Contributions to Cognitive Impairment

Award Number: R43AG069524
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2022

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Formulation of a Novel Therapeutic for Treating Cognitive Impairment in Patients at-risk for Alzheimer's Disease-Related Dementias and Vascular Contributions to Cognitive Impairment - Vascular contributions to cognitive impairment and dementia (VCID) and Alzheimer’s disease related dementias (ADRD) significantly contribute to the 47 million people world-wide who suffer with dementia. This number is estimated to increase to over 130 million people by 2050. A number of studies have shown that VCID and conversion to ADRD are strongly correlated with vascular disease, inflammation and decreased cerebral brain blood flow (1),(2),(3), (4),(5),(6), (7),(8). The relationship between vascular disease, cognitive function and progression to dementia and possible AD have been recently reviewed (9). These authors successfully make the case for a close relationship between cardiovascular risk factors and risk for VCID and ADRD. Furthermore, conversion rates of VCI to dementia has been reported to be within 40-46% within 5 years of diagnosis of VCI (10),(11). To date, there are no approved therapies for VCID. ProNeurogen has been working to develop novel Angiotensin 1-7 (Ang-1–7) formulations to treat inflammation-related cognitive impairment in patients at for risk ADRD and VCID. The goal of the present SBIR Phase I project is to begin feasibility studies to develop an extended release subcutaneous injection formulation for the administration of our novel peptide therapies to treat brain inflammation related cognitive impairment and VCID. These novel peptide formulations are designed to act on Mas receptors (MasR) within the brain vascular endothelium and neuronal cells and microglia to decrease brain ROS production and neuroinflammation. We have begun to translate these preclinical findings into novel peptide therapeutics to treat inflammation related cognitive impairment in patients with heart disease who are at risk for ADRD or VCID. We have an approved FDA IND # 125320 and support for Phase 2a trials for native Ang-(1-7) for treatment of cognitive impairment in heart failure (HF) patients and NIH support for our trial in cardiac bypass surgery patients (CABG). Our current approved treatment protocol for HF/VCID patients is once a day, subcutaneous 100 microg/kg injection using a standard needle and syringe for 85 days in our VCID/HF patients. However, in order to increase patient compliance, as well as accelerate commercialization we are currently investigating new formulations that are more patient friendly and require fewer injections. We will take advantage of Oakwood Labs’ extensive experience with extended release formulation of sterile injectables to complete the 2 principal objectives of this project: 1. Objective 1. Complete feasibility studies to develop extended release subcutaneous injection formulation of Ang-(1-7). 2. Objective 2. Complete comparative in vivo PK studies of the extended release injection formulations. Following successful completion of these feasibility studies, in Phase II we will conduct extensive PD studies of the PLGA-Ang-(1-7) formulation in our VCID animal model to establish the cognitive protective and brain anti-inflammatory effects of PLGA-Ang-(1-7) and ultimately begin IND enabling studies.


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: 2023 ( Subtotal = $0 )
2023	2020	PRONEUROGEN INC	1970 N WENTWORTH RD	TUCSON	AZ	85749	PIMA	USA	Aging Research	000	1	10/21/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	PRONEUROGEN, INC.	1970 WENTWORTH RD	TUCSON	AZ	85749	PIMA	USA	Aging Research	000	1	10/14/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	PRONEUROGEN, INC.	1970 WENTWORTH RD	TUCSON	AZ	85749	PIMA	USA	Aging Research	000	1	10/15/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $439,355 )
2020	2020	PRONEUROGEN, INC.	1970 WENTWORTH RD	TUCSON	AZ	85749	PIMA	USA	Aging Research	000	1	8/5/2020	NEW	$439,355
														Subtotal = $439,355

Grand Total All Awards = $439,355

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Formulation of a Novel Therapeutic for Treating Cognitive Impairment in Patients at-risk for Alzheimer's Disease-Related Dementias and Vascular Contributions to Cognitive Impairment

Award Number: R43AG069524

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2022

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