RedHill Biopharma rockets on positive results for RHB-104 in Crohn's disease

Gastrointestinal drug developer RedHill Biopharma (Nasdaq: RDHL) today announced positive top-line safety and efficacy results from the first Phase III study with RHB-104 for Crohn's disease (the MAP US study).

The study successfully met its primary endpoint and key secondary endpoints, said the Israel-based biotech, whose shares shot up 18.72% to425.00 shekels mid-morning on the much anticipated results, and leapt as much as 40% pre-market.

Top-line results in the intent-to-treat (ITT) population demonstrated superiority of RHB-104 over placebo in achieving remission at week 26, defined as Crohn's Disease Active Index (CDAI) value of less than 150, the primary endpoint of the study. The proportion of patients meeting the primary endpoint was significantly greater in the RHB-104 group compared to placebo (37% vs. 23%, p= 0.013).