Secondary endpoints reshape the debate

We refresh our investment thesis for SynAct Pharma following top-line results from the Phase IIb ADVANCE trial. While the trial missed the primary DAS28-CRP endpoint, we are encouraged by other strong efficacy signals, particularly the 76.4% ACR20 response rate at the selected 40mg dose, comparable to biologics and JAK inhibitors. Significant improvements in C-reactive protein (CRP) and the Simplified Disease Activity Index (SDAI), together with a favourable safety and tolerability profile, support resomelagon's pro-resolution mechanism, a potentially important differentiator in the autoimmune space. The upcoming end-of-Phase II (EoP2) meetings with the FDA and EMA will be critical in determining the regulatory pathway and Phase III stra...