In 2017, Immunovia announced impressing early results in the diagnostics of – and differentiation between – several different overlapping autoimmune diseases based on the IMMray™ technology platform i.e. Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome och Systemic Vasculitis. Consequently, the company decided to expand their strategy in the area of autoimmune disorders (press release March 7, 2017 and press release January 12, 2017).
This initial study data has been discussed with numerous Key Opinion Leaders in autoimmune rheumatic diseases. They all expressed great interest in the differential data, but they highlighted the need for more accurate and, most importantly, diagnosis of early RA.
In the RA field, healthcare recommendations for early diagnosis are already in place1 and ongoing implementation in the healthcare systems. This strong trend is important for a quick uptake and market penetration of a diagnostic test that would solve the bottlenecks described in the recommendations.
A third recently reported discovery study (press release Aug 22, 2018) showed a major breakthrough: an accuracy higher than 90% for IMMray™ biomarker signatures when diagnosing the CCP negative rheumatoid arthritis patients compared to healthy controls. These exceptionally good results have now triggered Immunovia’s strategic decision to focus on RA.
For the next step towards developing a commercial product, Immunovia has started to engage several Key Opinion Leaders in this field to design and run a study aiming to optimize the signature for differentiating the patients with early RA from the controls having other diseases than RA but exhibiting RA-like symptoms.
In SLE, the major clinical unmet need is monitoring SLE flares and treatment. Preliminary studies published in 20162 showed that IMMray™ platform could measure SLE high and low activity, but further large discovery studies with many samples per patient would be required to confirm these findings.
1. van Steenbergen HW, et al. Ann Rheum Dis 2016;0:1–6
2. Delfani P. et al, Deciphering systemic lupus erythematosus-associated serum biomarkers reflecting apoptosis and disease activity, Lupus 26(4) · September 2016