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Research: Healthcare
SynAct Pharma has announced top-line results from the Phase IIb ADVANCE study of resomelagon in rheumatoid arthritis (RA), delivering a mixed but clinically informative dataset. While the trial missed its primary DAS28-CRP endpoint, several secondary efficacy measures and inflammatory biomarkers were supportive of drug activity. Notably, the selected 40mg dose achieved a competitive ACR20 response rate of 76.4% versus 60.8% for placebo (p=0.06), with the treatment effect reaching statistical significance in the ACR/EULAR Class II–III subgroup (76.9% vs 56.5%; p=0.03), which comprised the majority of enrolled patients. Significant reductions were also observed in c-reactive protein (CRP) levels and improvements in the Simplified Disease Activity Index (SDAI), alongside a favourable safety profile with no evidence of immunosuppression. We view these findings as encouraging but believe that end-of-Phase II (EoP2) meetings with regulators will be critical in determining whether the data package is sufficient to support Phase III development. We will provide a more comprehensive update following further analysis.