SynAct has reported top-line results from its Phase IIb ADVANCE study evaluating resomelagon in newly diagnosed, treatment-naïve patients with rheumatoid arthritis.
In our view, the readout presents an encouraging dataset despite the study not achieving statistical significance on its primary DAS28-CRP endpoint, which appears to have been affected by a higher-than-anticipated placebo response.
Importantly, resomelagon demonstrated several clinically meaningful efficacy signals, including a 76.4% ACR20 response rate at the selected 40mg dose, significant reductions in C-reactive protein (CRP), a key marker of systemic inflammation, and improvements in the Simplified Disease Activity Index (SDAI), a validated measure of disease activity in rheumatoid arthritis.
We also note the favourable safety and tolerability profile, with no evidence of immunosuppression. The confirmation of a non-linear dose-response relationship and the identification of 40mg as the optimal dose provide additional support for future development.
We expect SynAct to engage with the FDA through an End-of-Phase II meeting to discuss the findings and align on the design of a potential Phase III programme.