RedHill Biopharma Ltd., an emerging biopharmaceutical company based in Israel focused on the development of small molecule drugs for the treatment of inflammatory and gastrointestinal diseases, recently announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted the company’s Clinical Trial Application (CTA) to begin a second Phase III clinical trial of RHB-104 for patients with Crohn’s disease.
The trial, called the MAP EU study, is expected to be initiated in a selection of countries in the European Union and will run in parallel with the ongoing MAP US first Phase III clinical trial.
RHB-104 is an antibiotic that has potent intracellular, anti-mycobacterial and anti-inflammatory properties that could offer promising therapeutic value for a disease such as Crohn’s, given the disease’s inflammatory underpinnings.
The MAP EU, a double-blind, placebo-controlled, randomized Phase III trial aims to randomize 360 patients with a moderately active diagnosis of Crohn’s disease. Patients will receive either RHB-104 or a placebo for a period of 52 weeks, and the primary endpoint is the evaluation of remission at week 26.
The compound is also being evaluated in a first Phase III study in the United States, Israel, Australia, Canada, New Zealand and Europe.
MAP US is a placebo-controlled, double-blind, randomized Phase III trial that aims to enroll a total of 270 patients with moderately to severely active, diagnosed Crohn’s disease. Patients will be randomized to either RHB-104 or a placebo for a treatment period of 52 weeks. The study’s primary endpoint is remission at week 26. The company is expecting to present results of an interim analysis during the second semester of 2016.
Aida Bibliowicz, RedHill’s VP, Clinical Affairs Europe, said in a recent press release: “We are very pleased that the CTA for the Phase III MAP EU study has been accepted by the UK MHRA. This is an important milestone for the development of RHB-104 for Crohn’s disease and represents a significant achievement in our ongoing preparations for the initiation of the second Phase III study for this drug candidate, to be conducted in Europe. The first Phase III MAP US study of RHB-104 for Crohn’s disease is currently ongoing in the U.S. and other countries, with approximately 80 of the planned 120 clinical sites already initiated.”