RedHill adds option for Phase 3 early stop in Crohn's
- RedHill Biopharma was upbeat on its conference call with analysts this week, announcing it will report a data read-out of an interim analysis in the second quarter of 2017. This could allow an early stop for success in its ongoing Phase 3 trial for its fixed dose oral antibiotic combination, and speed up the development timelines. This was matched with a modest uptick of 3.6% in the share price.
- The RHB-104 Phase 3 Crohn's disease study is on track, with 219 of 410 patients at 150 sites enrolled to date, and recruitment expanded across Europe to expedite EU approval. If the stop isn't triggered, it should complete full recruitment by the end of 2017.
- Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are incurable and affect as many as 1.6 million people in the U.S. VisionGain predicts that the market value will hit $9.3 billion in 2019, with biologics being the main sales drivers.
RedHill Biopharma is so confident in the success of its antibiotic-based treatment for Crohn's disease, RHB-104, that it has built in a new option that allows an early stop for "overwhelming efficacy," Dror Ben-Asher, RedHill’s CEO, explained in a conference call this week.
The company's work is based on links in the literature between Crohn's disease and a bug called Mycobacterium avium subspecies paratuberculosis (MAP). Patients have been treated with triple combinations of antibiotics for MAP infection for many years, with anecdotal reports of efficacy, but RedHill's clinical trials will put the treatment on a firmer (and approvable) footing.
While MAP infection may not be behind all cases of Crohn's disease, it could be responsible in susceptible patients, and to tie in with this, RedHill is creating a companion diagnostic that detects MAP DNA in the blood.
RedHill is also developing its antibiotic formulation for other diseases that don't look like infections – RHB-104 is also in a Phase 2a proof-of-concept study in multiple sclerosis, and preclinical assessment in rheumatoid arthritis.
- RedHill Biopharma Statement
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