Progentec Granted $1.7M to Validate Measure of SLE Disease Activity

Progentec, a company developing new diagnostic technologies for chronic conditions, has been awarded $1.7 million to validate its blood biomarker test as an accurate tool for measuring disease activity in systemic lupus erythematosus (SLE), the company announced.

The Fast-Track Small Business Innovation Research (SBIR) grant is from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH).

“We anticipate that the tests in development by Progentec will support clinicians in selecting optimal treatment plans, adjusting medication dosing, and measuring outcomes for lupus patients,” Mohan Purushothaman, PhD, CEO of Progentec, said in a press release.

Assessing a patient’s disease activity is fundamental not only for selecting the right treatment for the right person, but also for determining if an individual is responding to treatment. These determinations can avoid unnecessary rounds of treatment.

The most widely used disease activity measures for SLE, both in research and in clinical practice, are versions of the SLE Disease Activity Index (SLEDAI), including the SLEDAI-2K and the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI.

However, these methods require clinicians’ assessments — a subjective measure — and cannot predict how the disease will progress. Research has shown that SLEDAI-2K misses nearly two of out three patients with clinically meaningful changes in disease activity. The data show the need for more sensitive measures of disease activity for this patient population.

Progentec has been working on a new biomarker-based platform that offers multiple tests to manage various aspects of the disease — including diagnosis, disease tracking, and flare prediction.

The grant will be used to validate the biomarkers and methods used in Progentec’s disease activity test, called aiSLE DX – Disease Activity Index. The project will be led by Melissa Munroe, MD, PhD, and Eldon Jupe, PhD. The test is expected to be available by the end of 2019.

Being able to accurately measure disease activity may aid in better use of therapies, recruitment of patients for clinical trials, and measurement of responses to treatment.

The grant is part of NIAID’s mission to “conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.”

Given in two installments, the initial award will be $225,000. The grant has the potential to reach $1.7 million.

“Progentec has worked to identify relevant lupus biomarkers and methods of analysis. This grant offers us an opportunity to validate the prognostic value of these tests,” Jupe said.

The technology company is developing a biomarker-based test, called the aiSLE DX – Lupus Diagnosis Index, that is designed to diagnose lupus before patients develop symptom. Another test under development by Progentec, the aiSLE DX – Flare Prediction Index, aims at predicting the onset of flares weeks in advance.