- RedHill Biopharma (NASDAQ:RDHL) provides a business update of its main activities and key highlights expected in 2018.
- Key Highlights:Top-line results from the ongoing Phase III study with RHB-104 for Crohn’s disease (MAP US study) are expected in mid-2018. Enrollment of all 331 subjects has been completed and the last patient to reach the primary endpoint assessment is expected by early May 2018.
- Top-line results from the confirmatory Phase III study with TALICIA (RHB-105) for H. pylori infection (ERADICATE Hp 2 study) are expected in H2 2018. To date, ~60% out of a planned total of 444 subjects have been enrolled in the study.
- Amendment to RHB-106 agreement with Salix Pharmaceuticals relating to the
RHB-106 encapsulated bowel cleanser, as well as additional related rights. - Continued cost reduction in 2018.
- Additional Updates:First five patients enrolled in Phase IIa study with YELIVA (ABC294640) for the treatment of cholangiocarcinoma; Enrollment completion expected by the end of 2018.
- Ongoing discussions with the FDA on planned Phase III development programs for BEKINDA (RHB-102) for acute gastroenteritis and for IBS-D. RedHill plans to meet with the FDA in Q2 to discuss the design for one or two pivotal Phase III studies.
- A pivotal Phase III study with RHB-104 for the treatment of nontuberculous mycobacteria infections is expected to begin in H2 2018.
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