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Proteomic Profiling of Idiopathic Pulmonary Fibrosis Progression Trajectory

Award Number: R01HL169166
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Proteomic Profiling of Idiopathic Pulmonary Fibrosis Progression Trajectory - Project Summary Idiopathic pulmonary fibrosis (IPF) is a devastating interstitial lung disease characterized by progressive lung function decline survival worse than most cancers. Despite high mortality, the trajectory of IPF progression is highly heterogeneous. This heterogeneity hampers drug development, as large sample sizes are required when conducting IPF clinical trials to ensure enough patients experience forced vital capacity (FVC) decline to detect a treatment effect. The ability to predict IPF progression trajectory, however, remains elusive. Emerging proteomic platforms provide a valuable opportunity to address this gap in knowledge. In Aim 1, we will validate proteomic biomarkers of IPF progression. Using a high-throughput, semi-quantitative proteomic platform, we will determine plasma concentration for ~3000 analytes in the UK-based PROFILE cohort (n=550) and perform. targeted analysis of 258 preliminary biomarkers of one-year categorical IPF progression identified in a discovery cohort from the Pulmonary Fibrosis Foundation (n=813). In aim 2, we will derive and validate a proteomic signature of FVC trajectory. Machine learning will be applied to semi-quantitative proteomic data to select proteins for quantitative signature development. A custom, quantitative platform will be developed and used to quantify selected proteins, with data used to develop a proteomic signature of one-year FVC trajectory. This signature will then be assessed in three prospectively recruited IPF cohorts. In aim 3, we will determine whether anti-fibrotic therapy modulates biomarkers of IPF progression. Quantitative proteomic data will be generated for 240 treatment-naïve patients and repeated at 12-months after 80 patients each received pirfenidone, nintedanib or no therapy. Longitudinal change in biomarker concentration and test performance characteristics will be compared between treatment groups before and after anti-fibrotic initiation. Successful completion of this proposal will identify novel molecular mediators of IPF progression and result in a highly significant biomarker signature to predict IPF progression trajectory. This tool has high potential to speed drug development through clinical trial enrichment, making precision medicine a reality in patients with IPF.


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 = $685,748 )
2025	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	3	6/28/2025	NON-COMPETING CONTINUATION	$685,748
														Subtotal = $685,748

Issue Date FY: 2024 ( Subtotal = $680,289 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	2	6/8/2024	NON-COMPETING CONTINUATION	$680,289
														Subtotal = $680,289

Issue Date FY: 2023 ( Subtotal = $716,494 )
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	1	8/29/2023	NEW	$716,494
														Subtotal = $716,494

Grand Total All Awards = $2,082,531

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Proteomic Profiling of Idiopathic Pulmonary Fibrosis Progression Trajectory

Award Number: R01HL169166

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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