RedHill Biopharma Announces Last Patient Enrolled in the Phase III Study with RHB-104 for Crohn’s Disease

- Top-line results are expected to be announced in mid-2018

- The Phase III study evaluating RHB-104 for Crohn’s disease (MAP US study) is a randomized, double-blind, placebo-controlled study that is evaluating the safety and efficacy of RHB-104 in 331 subjects with moderately to severely active Crohn’s disease

- Worldwide sales of Crohn’s disease therapies exceeded $7.6 billion in 2016

- A pivotal Phase III study with RHB-104 for Nontuberculous Mycobacteria (NTM) infections, with Fast-Track development status, is planned to be initiated in H1/2018           


TEL-AVIV, Israel and RALEIGH, N.C., Nov 10 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the last patient has been enrolled in the Phase III study with RHB-104 for Crohn’s disease (MAP US study). Top-line results are expected to be announced in mid-2018.

The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study evaluating the safety and efficacy of RHB-104 in subjects with moderately to severely active Crohn’s disease (defined as Crohn’s Disease Active Index (CDAI) between 220 and 450). The primary endpoint of the MAP US study is disease remission, defined as a reduction in CDAI to less than 150 at week 26. The study enrolled 331 patients across approximately 150 clinical sites in the U.S., Canada, Europe, Israel, Australia and New Zealand.

Source : RedHill Biopharma Ltd.