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

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 1) clinical endpoints 2) prognostic markers of disease progression at baseline and 3) prognostic markers of disease progression that measure change over time and ultimately whether those biomarker measurements have greater prognostic ability of disease progression and/or are more predictive of treatment response than the existing standard of radiographic joint space narrowing (JSN). 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.

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.

Program Goals

  • Outline the optimal OA biomarkers that can replace the current radiographic joint space narrowing (JSN) measurement for diagnosis of knee OA in the clinic
  • Define the prognostic biomarkers that determine early progression of OA disease to stratify OA subjects and allow for enriched clinical trials with identified progressors
  • Determine predictive biomarkers that can be used to measure treatment response and efficacy of intervention to function as validated endpoints for use in clinical trials

Results & Accomplishments

Media

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

Partners

* indicates a funding partner

Arthritis Foundation*
Duke University
Kolon TissueGene, Inc.*
Merck KGaA, Darmstadt, Germany*
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Pfizer/Eli Lilly and Company*
Samumed, LLC*
University of Sydney

FNIH Contacts

Stephanie Cush, Scientific Project Manager, (301) 594-6649, scush@fnih.org