The treatment potential was further supported by a significant reduction of CRP which was not present in the placebo treated control group. In addition, resomelagon induced a larger reduction in the Simplified Disease Activity Index (SDAI). Overall, the safety profile of the compound was very good, and the compound was well tolerated. No signs of immune suppression were observed, states the company.

The ADVANCE study

The ADVANCE study was a multicenter, randomized, double-blind, placebo-controlled, 12-week study in newly diagnosed, treatment naïve patients with highly active Rheumatoid Arthritis (RA) conducted at sites in Europe and USA. 246 patients were randomized with the aim of confirming the potential of the compound as a novel safe treatment option in RA and identify feasible doses for further (phase 3) clinical development.

“We designed the study with the aim to confirm the potential of resomelagon as a new treatment option for early intervention in RA where there is a large need for novel well tolerated treatment option that can help control disease activity without inducing suppression of the immune system,” says Chief Scientific Officer, Thomas Jonassen, and continues “To our knowledge, the ACR20 response for resomelagon is on par with what has been reported for the very potent Janus Kinase (JAK) inhibitors upadacitinib and baricitinib. No other compounds, except glucocorticoids have shown ACR20 response rates above 75% following 12 weeks dosing.”

Business development and partnering update

“We are excited about the ADVANCE study and we are positive that the results will lay the foundation for a very constructive business development agenda ahead of us”, says Chief Executive Officer, Jeppe Øvlesen.

“The data supports a compelling profile and mechanism of action that could broaden the addressable market in RA, supporting competitive positioning across major patient groups, including those with compromised immune systems and individuals with hyperinflammatory responses to viral infections. Resomelagon is a “first-in-class” and the clinical proof of concept is what makes the results of ADVANCE so exiting”, says Chief Business Officer, Mads Bjerregaard.

The results from the ADVANCE study are expected to further fuel partnering and licensing discussions, the company states.