Additional data from phase III MAP-US study of RHB 104 confirms benefits in Crohn's.- RedHill Biopharma.

RedHill Biopharma reported additional positive data from the MAP US study, its first Phase III study of RHB 104 in the treatment of Crohn's disease. The MAP US study successfully met its primary endpoint and key secondary endpoints with meaningful and statistically significant treatment effects, including the primary endpoint of clinical remission at week 26 (37% vs. 23%, p=0.007) and key secondary and other efficacy endpoints of clinical response at week 26 (44% vs. 31%, p=0.016), early clinical remission at week 16 (42% vs. 29%, p=0.015), clinical remission at weeks 16 and 52 (25% vs. 12%, p=0.003) and durable clinical remission on all visits, weeks 16 through 52 (18% vs. 9%, p=0.018). These previously reported outcomes were further enhanced when stratified for concomitant anti-TNF agent use as prospectively specified in the statistical analysis plan. The data was provided to RedHill by an independent third party CRO following an independent analysis and remains subject to completion of the Clinical Study Report (CSR).

The presentation highlighted new positive week 26 remission data showing the impact of RHB 104 as an add-on therapy to a variety of SoC agents. Despite not being prospectively powered, meaningful and statistically significant treatment effects (RHB 104 vs. placebo) were observed in patients using concomitant immunomodulators (39% vs. 20%, p<0.01) and corticosteroids (36% vs. 20%, p="0.045)" throughout the trial. furthermore, despite very small sample sizes of the following subgroups of patients and lack of prospective powering, strong trends in favor of rhb 104 were also observed in patients receiving anti-tnf agents achieving remission at week 26 (36% vs.17%, p="0.08)" (total patients analyzed="67)" and the proportion of patients achieving corticosteroid-free remission at week 52 (24% vs. 6%, p="0.175)" (total patients analyzed="37)." additionally, in a small subset of patients in whom endoscopy was performed, the study also showed statistical significant improvement in endoscopic healing at week 26 (36% vs. 10%, p="0.048)" (total patients analyzed="35)." this data confirms the broad benefit of rhb 104 as add-on therapy to soc in crohn's disease.></0.01)>

RHB-104 was also found to be generally safe and well tolerated with similar treatment-emergent adverse events, serious adverse events and adverse events leading to study drug discontinuation experienced between treatment groups. An abstract discussing the study's top-line results, A Phase III Randomized, Double Blind, Placebo-Controlled, Multicenter, Parallel Group Study To Assess The Efficacy And Safety Of Add-On Fixed-Dose Anti-Mycobacterial Therapy (RHB-104) In Moderately To Severely Active Crohn's Disease (MAP US) was presented as a late-breaking abstract at the United European Gastroenterology Week.