Early Intervention in Inflammatory and Autoimmune
Resomelagon is primarily being developed for treatment of Rheumatoid Arthritis (RA).
Our phase IIb study focus on helping newly diagnosed rheumatoid arthritis patients, who have a high disease activity including signs of systemic inflammation and where treatment with disease modulating antirheumatic drugs (DMARD) has not been initiated. In other words, resomelagon is given as first line treatment together with Methotraxate.
RA patients are today treated based on international Treatment Guidelines. Newly diagnosed RA patients are initially treated with the conventional DMARD methotrexate (MTX). Nevertheless, these patients often need co-treatment with other medicines like glucocorticoids (GCs) and in many cases biologic DMARDs (second line), typically a TNF-blocker, to get rheumatoid arthritis under control.
Both GCs and biologic DMARDs are associated with unwanted side effects, as is JAK-inhibitor. Therefore, these drugs are recommended as second line RA treatment. Biologic medicine is expensive (even if biosimilars have been marked) as is JAK-inhibitors. Overall, current RA-treatment is quite costly for society.
The Clinical Development Program for resomelagon has been designed to address the huge Unmet Need within RA-treatment. It is anticipated that resomelagon will be an important novel new medicine contributing to close current gaps within RA:
- Fit into existing Treatment Guidelines.
- Can be given early in RA treatment (newly diagnosed RA patients).
- Be a First-line Treatment combination with Methotrexate.
- Increase disease control (remission or low disease activity) – increase efficac.y
- Have a very favorable adverse event profile.
- Avoid suppression of the immune system and potential infections (decreased use of GC and bDMARDS).
- A convenient once a day tablet.
- A cost-effective treatment.
- Has the potential to save costs for society.
Resomelagon is expected to provide a unique first line patient-friendly treatment for newly diagnosed RA patients together with MTX to increase early disease control (efficacy) and at the same time reduce the need for GCs and potentially delay and reduce the need for second line treatment options including the TNF-blockers. Several phase 2 studies have been conducted in RA to gain knowledge about resomelagon in RA patients and characterize the safety profile in this population.