# Sample Collection and Analysis to Support the Qualification Plan for Drug Induced Skeletal Muscle Injury Biomarker Panel for DDT-BMQ-000081.

> **NIH FDA U01** · CRITICAL PATH INSTITUTE · 2021 · $249,769

## Abstract

ABSTRACT
This project seeks to increase our understanding of the sensitivity of the four proposed
skeletal muscle injury biomarkers to detect drug-induced skeletal muscle injury (DIMI), which
will address an unmet need in drug development for detecting and monitoring DIMI. The
evidence generated by this project is necessary to support the qualification of four skeletal
muscle specific proteins (skeletal troponin I (TNNI2), myosin light chain 3 (MYL3). Fatty acid
binding protein 3 (FABP3), and creatine kinase MM (CKM)) as biomarkers of skeletal muscle
injury by the Food and Drug Administration’s (FDA’s) Biomarker Qualification Program
(BQP). This qualification effort is being led by the Predictive Safety Testing Consortium’s
Skeletal Muscle Injury Working Group, for which these four biomarkers serve as safety
biomarkers to detect DIMI was accepted into the Biomarker Qualification Program. In order
to progress to the next stage of qualification, the Skeletal Muscle Injury Working Group must
prepare a Qualification Plan which summarizes the performance of these four biomarkers in
the learning phase studies and proposes the confirmatory studies to support the proposed
context of use under consideration by the Biomarker Qualification Program. To date, the
Skeletal Muscle Injury Working Group has limited clinical data in DIMI or muscle injury
populations. To address this gap, the Critical Path Institute (C-Path) proposes the following
research aim. Specific Aim 1 will conduct a study to determine the sensitivity of the proposed
drug-induced muscle injury biomarkers (TNNI2, MYL3, FABP3, and CKM). The study will
collect single samples from 125 subjects at the University of Michigan Hospital with
adjudicated skeletal muscle injury due to DIMI, skeletal muscle injury, or skeletal muscle
disease and 125 healthy subjects. This study will support the future submission of a
Qualification Plan for DDT# DDTBMQ000081 by defining the sensitivity of the proposed
drug-induced muscle injury biomarkers in muscle injury patients.

## Key facts

- **NIH application ID:** 10411471
- **Project number:** 1U01FD007466-01
- **Recipient organization:** CRITICAL PATH INSTITUTE
- **Principal Investigator:** Nicholas King
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $249,769
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10411471

## Citation

> US National Institutes of Health, RePORTER application 10411471, Sample Collection and Analysis to Support the Qualification Plan for Drug Induced Skeletal Muscle Injury Biomarker Panel for DDT-BMQ-000081. (1U01FD007466-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10411471. Licensed CC0.

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