Lupus Experts Gather at the FDA to Explore Potential for Biomarkers to Accelerate Clinical Trials

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Two Investigators Present Discoveries Funded by Lupus Research Institute

Biomarkers, potential indicators to monitor disease progress and treatment success, are among the most challenging and critical areas of lupus research according representatives of industry, academia, government and advocacy attending a U.S. Food and Drug Administration workshop this week. The meeting was convened to focus on the development of biomarkers to predict acute worsening of disease, called a flare, and their potential for accelerating lupus clinical trials and new drug approvals.

Scientists from academia and the pharmaceutical industry shared new data from clinical trials and studies looking at the effectiveness of biomarkers in predicting and monitoring the course of the disease. Biomarker is typically defined as a measurable substance that increases or decreases according to the degree of disease, taking much of the guesswork out of determining treatment and patient responses to treatment.

The Lupus Research Institute (LRI) was one of the earliest supporters of lupus biomarker research, launching a strategic research program in novel biomarker discovery nearly a decade ago. Since, LRI has invested $5.6 million in 20 biomarker studies, many of which are now concluding with promising results.

“The Lupus Research Institute exists to find a cure to lupus, and ten years ago we followed the counsel of our scientific advisory board to initiate a biomarker discovery drive as one way to speed up that journey,” noted LRI president Margaret G. Dowd. “Those innovative seeds we planted are already bearing fruit. As we’ve seen today, two of the studies presented at this conference may provide a catalyst for drug development and clinical trials in the not-so-distant future.”

Ms. Dowd pointed to presentations by Drs. Emily Baechler Gillespie at University of Minnesota’s Institute of Human Genetics, and Maureen McMahon at UCLA David Geffen School of Medicine as noteworthy examples of the research the LRI has supported in biomarkers. Dr. Gillespie’s longitudinal study looked at using biomarkers to predict when the disease will flare. The serum chemokine test her team developed has been licensed for commercial development.

“Without our funding from the LRI, we would not have had the opportunity to pursue the biomarker discovery and validation studies that led to the development of the serum chemokine test,” commented Dr. Gillespie. “The willingness of the LRI in particular to support biomarker discovery in human samples was instrumental in our research.”

Work presented by Dr. McMahon showed promise in using biomarkers to predict risk for disease flare and worsening of atherosclerosis for lupus patients. First identified with her colleague at UCLA, Bevra Hahn, MD through an LRI grant, one of these biomarkers is an abnormal plaque-promoting molecule in the blood called piHDL (pro-inflammatory high density lipoprotein).

“We are encouraged by the wealth of discoveries of new biomarkers and by the willingness that pharmaceutical companies have shown this week to share biomarker data with each other and the academic community” commented Ms. Dowd. “The challenge now is for companies and researchers to forge new working relationships in order to overcome the roadblock of validating these biomarkers and moving them into use in clinical trials. We look forward to facilitating this process.”

About Lupus
Lupus is a chronic, complex and prevalent autoimmune disease that affects more than 1.5-million Americans. More than 90% of lupus sufferers are women, mostly young women between the ages of 15 to 44. Women of color are especially at risk. In lupus, the immune system, which is designed to protect against infection, creates antibodies that attack the body’s own tissues and organs — the kidneys, brain, heart, lungs, blood, skin, and joints. Lupus is difficult to diagnose, difficult to treat, and is a leading cause of premature cardiovascular disease, kidney disease and stroke among young women. While there is no known cause or cure, the progress of recent discoveries is highly promising.

About the Lupus Research Institute
The Lupus Research Institute (LRI), the world’s leading private supporter of innovative research in lupus, pioneers discovery and champions scientific creativity in the hunt for solutions to this complex and dangerous autoimmune disease. Founded by families and shaped by leading scientists, the LRI mandates sound science and rigorous peer review to uncover and support only the highest ranked novel research to prevent, treat and cure lupus.

With its National Coalition of state and local lupus organizations, the LRI is dedicated to finding new and safer options for treating the disease by improving the design of clinical studies and promoting broad participation in clinical trials.

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Kristen Teesdale

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