Synact Pharma: Post-hoc analysis strengthens Phase III case - Edison
SynAct Pharma has reported further analysis of the Phase IIb ADVANCE study (testing resomelagon in rheumatoid arthritis), providing a clearer explanation for the unexpectedly strong placebo response.
ANNONS
Management estimates that around 20% of patients entered the study during a temporary inflammatory flare, with this subgroup accounting for much of the variability observed in the placebo arm.
Excluding these patients, the 40mg resomelagon achieved an ACR20 response of 79% versus 55% for placebo (p<0.05), alongside greater separation in ACR50 and DAS28 improvements.
We believe the analysis strengthens the overall interpretation of ADVANCE and should provide useful support for upcoming regulatory discussions.
Importantly, we believe that these findings offer a practical framework for the Phase III design, where tighter selection of patients with stable baseline inflammatory activity should be as important as demonstrating deeper and more durable responses over the proposed 26-week treatment period.
