SynAct Pharma announced additional data from the EXPAND P2b clinical trial supporting continued development of the compound in rheumatoid arthritis. SynAct previously released a post-hoc analysis of the EXPAND trial of once-daily oral resomelagon in treatment naive rheumatoid arthritis patients who had an elevated baseline level of C-reactive protein (CRP> 3mg/L), marker of systemic inflammation. To further this assessment, a subset analysis of the elevated baseline CRP patients who were enrolled within 6 months of their diagnosis of rheumatoid arthritis (RA) was conducted.

In this subpopulation of patients, 100mg of daily resomelagon demonstrated a consistent and statistically significant response to therapy over placebo across assessed outcome measures. At 12 weeks in EXPAND patients with elevated baseline CRP, the 100mg resomelagon group had an ACR20 attainment of 71% as compared to 54% of placebo patients. At 12 weeks in the subpopulation of patients with elevated CRP who were enrolled and had treatment initiated within 6mo of their RA diagnosis, 23 out of 28 (82%) of patients treated with 100mg resomelagon attained an ACR20 compared to 14 out of 27 (52%) of placebo patients (P<0.05).

A significant difference favoring resomelagon was also seen across the secondary outcome measures including the reduction in CDAI (resomelagon 24.6 vs placebo 14.7 points, p<0.01), reduction in DAS28-CRP (resomelagon 1.9 vs placebo 1.2 points, p<0.001), and reduction in HAQ disability index (0.69 vs placebo 0.31 points, p<0.05). Safety in the elevated CRP population with treatment within 6 months of was comparable to what has been previously reported for the full EXPAND study population.