Thursday, December 26, 2024 12/26/2024

Towards full qualification of cT1 and PDFF as enrichment biomarkers for drug development: Characterising performance in the target population

Award Number: U01FD006880
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By:

View Award Abstract

Abstract In this project, Perspectum Diagnostics seeks to complete the necessary evidence to qualify the MRI imaging biomarkers iron-corrected T1 (cT1) and PDFF as Drug Development Tools for NASH. Both cT1 and PDFF show promise as diagnostic enrichment biomarkers. They are envisioned to be used in in conjunction with clinical risk factors, to identify patients who are more likely to have liver histopathologic findings appropriate for inclusion in non-alcoholic steatohepatitis (NASH) clinical trials. We also believe that they both have potential as pharmaco-dynamic efficacy biomarkers to be used as endpoints in clinical trials. With the funding from this U01 Cooperative Agreement proposal and leveraging the close collaboration with the FDA, we will perform a biopsy-paired case-control observational study in 60 patients. The aims of this study are two-fold and interdependent: · To demonstrate that a binary decision algorithm applied to cT1 (and/or PDFF) can significantly identify patients whose liver biopsy results would qualify them for randomization in a clinical trial testing an investigational treatment for NASH with fibrosis · To determine the measurement repeatability of cT1 and PDFF in the target patient population by examining the test-retest variability, with the ultimate objective to establish agreement around tightly defined cut-offs. The study will be performed by the Texas Liver Institute who will include a representative sample of their patient population over a period of 6 months.


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	2019	PERSPECTUM, INC	400 OYSTER POINT BLVD	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	000	1	1/3/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	PERSPECTUM INC.	400 OYSTER POINT BLVD STE. 435	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	001	1	8/6/2021	NEW	$0
2021	2019	PERSPECTUM INC.	400 OYSTER POINT BLVD STE. 435	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	000	1	1/5/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	PERSPECTUM DIAGNOSTICS INC.	400 OYSTER POINT BLVD STE. 435	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	001	1	8/4/2020	NEW	$0
2020	2019	PERSPECTUM DIAGNOSTICS INC.	400 OYSTER POINT BLVD STE. 435	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	000	1	2/4/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $249,940 )
2019	2019	PERSPECTUM DIAGNOSTICS INC.	400 OYSTER POINT BLVD STE. 435	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	000	1	9/3/2019	NEW	$249,940
														Subtotal = $249,940

Grand Total All Awards = $249,940

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Towards full qualification of cT1 and PDFF as enrichment biomarkers for drug development: Characterising performance in the target population

Award Number: U01FD006880

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer