Identifying proteomic biomarkers to predict the course of early RA

Purpose and goal:

Lipum has developed a therapeutic antibody (SOL-116) for treatment of rheumatoid arthritis (RA). SOL-116 targets the bile salt-stimulated lipase (BSSL) and is currently being tested in a phase 1 clinical trial. Early and efficient treatment is crucial to prevent or slow the progression of the disease in RA.

The goal of the current project is to define a panel of carefully selected biomarkers that correlate with disease activity and BSSL levels in the blood and can predict the response to treatment with SOL-116. Expected results and effects:

Increased knowledge of the relationship between BSSL and biomarkers linked to disease activity and prognosis in RA is of great importance, not least to be able to predict patients´ response to treatment with the drug candidate SOL-116. The results from this project are expected to pave the way for an optimized design of clinical studies and lay the foundation for the development of a SOL-116 companion diagnostic test to predict the response to SOL-116.

This may in the future increase the chance of SOL-116 reaching the market and enable personalized and effective therapeutic strategies. Approach and implementation:

Work package (WP) 1 covers administrative, financial, ethical, data and business development. In WP2, BSSL is analyzed in blood samples taken at different time points from individuals with an increased risk of RA, patients with newly diagnosed RA and healthy controls. In WP3, thousands of biomarkers are analyzed in blood samples from the same individuals as above using Olink Explore panels.

WP3 also includes bioinformatic analysis of the results from WP2 (BSSL) and WP3 (Olink) with the aim to discover biomarkers that correlate with disease activity and BSSL blood levels in RA patients.