Exagen Inc. Announces Clinical Trial Conducted at Major Academic Center in Distinguishing Type 1 and Type 2 Lupus

Duke Lupus Clinic is focused on diagnosing, treating, and providing expert care to patients living with lupus.

SAN DIEGO, June 03, 2020 (GLOBE NEWSWIRE) — Exagen Inc. (Nasdaq: XGN), an organization dedicated to transforming the care continuum for patients suffering from autoimmune diseases, announced today a clinical trial in collaboration with Duke University in Durham, NC. 

This prospective study will evaluate biomarkers, including the AVISE panel and Cell-Bound Complement Activation Products (CB-CAPs), that distinguish between changes in subsets of lupus patients with Type 1 and Type 2 systemic lupus erythematosus (SLE) activity. The Type 1 and Type 2 SLE model was developed at Duke by Megan E.B. Clowse, MD, David Pisetsky, MD, PhD, Jennifer L. Rogers, MD, and colleagues as a means to incorporate the full spectrum of lupus symptoms into the clinical assessment and advance personalized medicine for lupus patients. The model combines patient- and physician- reported measures to group patients into two main categories. Type 1 manifestations are the classical lupus signs and symptoms due to inflammatory processes, and include butterfly rash, joint inflammation, nephritis or vasculitis. Patients categorized as Type 2 have a general feeling of being unwell and may present with fatigue, depression, anxiety, widespread pain, or difficulty sleeping.

“We’re pleased to be partnering with Duke to study Exagen’s proprietary CB-CAPs biomarkers in patients with lupus,” said Ron Rocca, President and CEO of Exagen. “A better understanding of the presentation and severity of lupus patients’ symptoms will help further the classification of disease severity.”   

“This collaboration will be the first to apply CB-CAPs to the Type 1 and Type 2 SLE model,” added Jennifer Rogers, Director of Duke Lupus Clinic. “When combined with clinical phenotyping, this study will determine whether the use of these biomarkers could lead to a more precision-medicine approach to lupus care and, potentially, improvements in patient outcomes.”

About Exagen Inc.

Exagen is dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases by enabling timely differential diagnosis and optimizing therapeutic intervention. Exagen has developed and is commercializing a portfolio of innovative testing products under its AVISE® brand. Several of these products are based on our proprietary Cell-Bound Complement Activation Products (CB-CAPs), technology. CB-CAPs assess the activation of the complement system, a biological pathway implicated in systemic lupus erythematosus (SLE). Exagen’s goal is to enable rheumatologists to improve care for patients through the differential diagnosis, prognosis and monitoring of complex autoimmune and autoimmune-related diseases, including SLE and rheumatoid arthritis, or RA. Exagen’s model of integrating testing products and therapeutics positions Exagen to offer targeted solutions to rheumatologists and, ultimately, better serve patients.  For more information, please visit www.Exagen.com 

Forward Looking Statements

Exagen cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, express or implied statements regarding the collaborative clinical trial and potential advantages of applying our CB-CAPs technology in Type 1 and Type 2 SLE.  The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation: the COVID-19 pandemic may continue to adversely affect our business, financial condition and results of operations, including as a result of shutdowns of our facilities and operations as well as those of our suppliers, courier services and our collaborators,  disruptions to the supply chain of material needed for our tests and our ability to receive specimens and perform or deliver the results from our tests, and delays in the planned clinical trial with Duke; and other risks described in the company’s prior press releases and the company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Exagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.