RedHill Announces Positive Feedback On European Phase III Plan For RHB-104

(RTTNews) - RedHill Biopharma Ltd. (RDHL) said that it had recently concluded Scientific Advice Meetings with the UK Medicines and Healthcare Products Regulatory Agency or MHRA and the Swedish Medical Products Agency or MPA regarding the regulatory path towards a Phase III clinical study in Europe with RHB-104.

The company said RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy with potent anti-bacterial and anti-inflammatory properties, in oral pill form, targeting Crohn's disease, multiple sclerosis, rheumatoid arthritis and other unmet medical needs. Crohn's disease is an inflammatory disease of the gastrointestinal system.

Following positive feedback from the UK MHRA and the Swedish MPA, the company believes there is a clear regulatory path towards a Phase III clinical study in Europe with RHB-104 for the treatment of Crohn's disease or the "MAP Europe" study.

The company said it intends to file applications to begin the Phase III MAP Europe study in several European countries and, working with a leading international CRO, has already identified potential sites for the study.

The company noted that it plans to commence a first Phase III double-blind placebo-controlled clinical study with RHB-104 for the treatment of Crohn's disease, enrolling 240 subjects in up to 50 sites in North America and Israel or the "MAP US" study in the coming weeks. The MAP Europe study will commence as soon as possible following the initiation of the MAP US study, in order for the two studies to be conducted in parallel. The company also intends to complete supplemental clinical and other studies as part of the regulatory plan.

The Phase III double-blind placebo-controlled MAP Europe study is expected to enroll 360 subjects with moderately active Crohn's disease randomized in up to 60 sites in six European countries. Similar to the MAP US Phase III study in North America and Israel, the MAP Europe study will be designed to assess the safety and efficacy of fixed-dose combination RHB-104 as well as to initially assess the role of MAP (Mycobacterium avium paratuberculosis) in Crohn's disease.

The primary endpoint for the MAP Europe study will be the state of remission at week 26 in subjects randomized to receive RHB-104, as compared to subjects randomized to receive placebo. Secondary and exploratory endpoints will include, among others, state of response at 26 weeks, maintenance of remission through week 52 and efficacy outcome measures in relation to the presence of MAP bacterial infection.

RHB-104 is also being evaluated for the treatment of multiple sclerosis (MS) and rheumatoid arthritis (RA). A Phase IIa, proof of concept, clinical study with RHB-104 for the treatment of MS is currently underway in Israel.