Israel-based RedHill Biopharma Ltd. recently disclosed it has been granted authorization to begin enrolling patients in Australia and New Zealand for a Phase III clinical trial designed to test RHB-104 as a potential treatment for Crohn’s disease. The company has already commenced screening of study participants in New Zealand. RHB-104 is an innovative orally available, combined antibiotic that features enhanced intracellular, anti-mycobacterial and anti-inflammatory properties.
The Phase III MAP US study for Crohn’s disease is currently underway in more than 80 of 120 planned clinical testing sites worldwide, and is a randomized, double-blind, placebo-controlled clinical trial that aims to enroll 270 patients diagnosed with a moderate to severe form of the disease. Study participants are then randomized 1:1 to be given either the medication or a placebo for a span of 52 weeks, before being evaluated for the primary endpoint of disease remission come the 26th week of treatment. RedHill expects the MAP US study to arrive at interim results within the second half of 2016, after approximately half of the aimed number of participants have been enrolled and have completed 26 weeks.
“The addition of Australia and New Zealand to RHB-104’s Phase III Crohn’s study, currently ongoing in the U.S. and additional countries, should further boost the study’s reach and pace,” said Dror Ben-Asher, RedHill’s CEO. “We are particularly excited about the addition of these two countries because the RHB-104 formulation was originally developed in Australia by Professor Thomas Borody, a leading innovator of therapeutic approaches for GI diseases, and an Australian Phase III study was conducted by Pfizer with an earlier formulation of the drug.”
The company is also planning to launch a second Phase III study for Crohn’s disease, which Clinical Trial Application (CTA) has been accepted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). This MAP EU study is expected to begin in a number of European territories and will proceed simultaneously with the ongoing MAP US study. The former will be randomized, double-blind, and placebo-controlled, and will enroll 360 patients with moderate Crohn’s disease, to be randomized 2:1. The study will also run for 52 weeks, with primary endpoint evaluation to commence at week 26.