RABIOPRED - Clinical validation of BIOmarker assay to PREDict treatment response in Rheumatoid Arthritis (RA) patients

Patients suffering painful rheumatoid arthritis could get better treatment in the future, thanks to a test developed on EU project RABIOPRED by a French SME.

Between 0.1 % and 5 % of the world’s population suffers from Rheumatoid Arthritis, a chronic autoimmune disease that causes swelling in joints. Many patients waste up to six months taking treatments that don’t help ease their pain, says French company TcLand Expression.

But the company says that could change for millions thanks to a non-invasive blood test it is commercialising after trials completed on project RABIOPRED. The test helps doctors spot those patients who won’t respond to TNF-α inhibiting agents, some of the most common treatments on the market, which cost the global healthcare industry € 38.8 billion in 2017.

TNF-α inhibiting agents aren’t suitable for 30-40 % of patients currently given them. However, doctors often have to give these expensive treatments to patients to find that out. They switch treatments when patients report continued pain or even serious side effects.

“With the RABIOPRED test, a rheumatologist would make an optimal treatment decision even before the start of the treatment,” said Prof. Hüseyin Firat, project coordinator.

TcLand had spent €26 million developing and patenting its RABIOPRED IVD test, which uses a novel gene expression signature and a predictive model. But the project needed to complete an analytical validation and clinical performance evaluation to commercialise it.

Taking it to the market

Thanks to the Horizon2020 funding, it was able to complete crucial steps towards getting the product to market. The team fully validated a RABIOPRED RUO (for research and investigational use only) test, which is now being sold to academics and pharmaceutical companies who want to develop personalised medicine applications.

Researchers also managed to complete the analytical and initial clinical validation of the first generation RABIOPRED IVD test for three of the most commonly used anti-TNF alpha biologicals: Infliximab, Etanercept and Adalimumab.

It is now extending the test to the other biologicals and looking for cooperation with academics and pharmaceutical companies in order to complete the clinical validation for them all. “We hope to keep the RABIOPRED study ongoing so that we can enroll 720 patients to pursue validating the test for all anti-TNF alpha biologicals,” said Prof. Firat.

TcLand forecasts a CE-marked IVD kit will be available commercially in the fourth quarter of this year once it completes a clinical proof-of-performance study. A panel of European Medicines Agency experts advised on the clinical study protocol and on the project’s clinical qualification strategy.

Research like this is tough for small and medium-sized companies. TcLand had to expand the number of study sites it had initially planned to find enough patients being prescribed the anti-TNF treatments it wanted to study.

But persistence paid off. Rheumatologist specialists who took part in the research gave positive feedback and pharmaceutical companies are interested. The company has signed a non-exclusive licence with HTG Molecular Diagnostics to manufacture RABIOPRED RUO and a non-exclusive distribution deal with a Contract Research Organisation (CRO) to provide biomarker services. TcLand is negotiating with a university hospital in France about opening a centre for RABIOPRED testing.

The test improves individual patient treatment while cutting care costs for insurers and public health systems. “RABIOPRED CE-IVD would decrease the management cost of Rheumatoid Arthritis significantly,” said Prof. Firat.

Reference source: RABIOPRED - Clinical validation of BIOmarker assay to PREDict treatment response in Rheumatoid Arthritis (RA) patients