SynAct Pharma AB announced it has initiated the filing process with submission in the US for a Phase 2b randomized, double-blind placebo controlled clinical multi-center study with the company's lead compound resomelagon (AP1189) to be conducted at sites in the US and in Europe. Resomelagon is a biased melanocortin receptor type 1 and 3 agonist that in Phase 2 clinical trials in newly diagnosed RA patients with high disease activity and signs of systemic inflammation showed significant treatment effect compared to placebo treatment with a good safety profile supporting first line treatment with the compound in combination with methotrexate (MTX). The primary aim of the ADVANCE study is therefore to confirm the treatment potential of the compound and to identify optimal doses for Phase 3 development in patients with severe newly diagnosed RA.

The ADVANCE study is set up as a double-blind placebo controlled multi-center study testing three doses of resomelagon (40, 70, 100 mg) given once daily for 12 weeks in combination with MTX treatment in patients showing signs of severe RA (DAS28-CPR >5.1; CDAI >22) including signs of systemic inflammation defined as hsCPR to be above normal range (>3 mg/L). The study is designed to randomize 240 patients using treatment induced reduction in DAS28-CRP as the primary efficacy readout in complete accordance with the current guidelines from FDA and EMA. The study will be conducted at clinical sites in the US and in Europe.

The submission in the US will be followed by submission of clinical trials applications in Europe in the upcoming weeks. It is the intention to have active recruitment up running in late third quarter 2024 with enrolment of all patients to be completed in fourth quarter 2025.