SynAct Pharma AB has announced EU approval for its Phase 2b ADVANCE study evaluating resomelagon (AP1189) in patients with newly diagnosed severe rheumatoid arthritis (RA). This double-blind, placebo-controlled study will assess the efficacy and safety of three different doses of resomelagon in combination with methotrexate (MTX) as a first-line treatment option.
ADVANCE Study Design and Objectives
The ADVANCE study is designed to enroll 240 patients diagnosed with severe RA within the past 6 months (DAS28-CRP >5.1; CDAI >22) and exhibiting signs of systemic inflammation (hsCRP >3 mg/L). Participants will be randomized to receive either placebo or one of three doses of resomelagon (40, 70, or 100 mg) once daily for 12 weeks, alongside MTX treatment. The primary endpoint is the treatment-induced reduction in DAS28-CRP, aligning with FDA and EMA guidelines.
Thomas Jonassen, CSO at SynAct Pharma, stated, "We are very pleased that we, following the approval in the EU though the centralized Clinical Trial Approved System (CTIS), can now continue with active patient recruitment and dosing at more than 20 sites in a total of 7 countries across Europe and the US. We expect the recruitment pace to accelerate and to have all 240 patients enrolled in Q4 2025."
Resomelagon: A Novel Approach to RA Treatment
Resomelagon (AP1189) is a biased melanocortin receptor type 1 and 3 agonist administered orally once daily. Unlike traditional RA therapies that suppress the immune system, resomelagon aims to resolve inflammation, potentially offering an effective treatment option without the safety risks associated with immunosuppression. The drug has shown promise in earlier studies, including the BEGIN study and a subset analysis of newly diagnosed patients with systemic inflammation in the EXPAND study.
The ADVANCE study seeks to confirm resomelagon's treatment potential and identify optimal doses for Phase 3 development in newly diagnosed RA patients. The trial's design reflects a commitment to developing patient-friendly, first-line treatments that address the underlying inflammatory processes in RA without compromising patient safety through broad immune suppression.
