Biomarkers Consortium - PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers

The goal of this three-year project is to validate the novel radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, and to qualify those biomarkers via the formal regulatory qualification process with both the FDA and EMA.

Overview

The Biomarkers Consortium’s PROGRESS OA - Clinical Evaluation and Qualification of Osteoarthritis Biomarkers Project is the second phase of a two-stage strategy to address the most fundamental obstacles to the development of new treatments for Osteoarthritis (OA). This project will validate the highest performing radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, which was completed in 2015. The PROGRESS OA Project utilizes data from previously conducted clinical trials to determine the imaging and biochemical biomarkers that can be used as prognostic markers of disease progression at baseline and prognostic markers of disease progression that measure change over time. The results from this study will be used in a regulatory qualification submission package to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to qualify the biomarkers for use in OA drug development.

The lack of tools for early diagnosis and measures to predict disease progression in OA continues to be a major hurdle in drug development, and there are currently no validated clinical biomarker endpoints for OA. The results of PROGRESS OA Project will provide a set of qualified biomarker tools that will impact clinical trial design by decreasing the number of patients needed, and decreasing the time and costs needed for OA drug development. The PROGRESS OA Project is a 3-year, $2.5 million project, which launched in 2018, scheduled to complete in 2021.

Partners

Public-Sector Partners

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Private-Sector Partners

  • Arthritis Foundation*
  • Merck KGaA, Darmstadt, Germany*
  • Novartis*
  • Pfizer/Eli Lilly and Company*
  • Samumed, LLC*

Academic Partners

  • Duke University
  • University of Sydney

*Provided financial or in-kind support for this program.

FNIH Contacts

Goals

  • Qualify radiographic, MRI and biochemical biomarkers with the FDA as prognostic biomarkers of knee OA disease in order to stratify patients and allow for enrichment of clinical trials with identified OA progressors.

Results & Accomplishments

Regulatory

The FDA has accepted three PROGRESS OA LOIs. They can be found below:

Media

  • FNIH Web Announcement (August 2, 2018): FNIH Biomarkers Consortium Launches Project Seeking Regulatory Qualification of Biomarkers for Measuring Knee Osteoarthritis  Read more