RedHill Biopharma, a speciality biopharmaceutical company headquartered in Israel, has announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn’s disease (the MAP US study).
RHB-104 is a proprietary, orally-administered antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties. The MAP US study — a randomized, double-blind, placebo-controlled first Phase III study — is evaluating the efficacy and safety of RHB-104 in patients suffering from moderately to severely-active Crohn’s disease. This study is ongoing in up to 150 clinical sites in the US, Canada, Europe, Israel, Australia and New Zealand with a long-term population pharmacokinetic (pop-PK) study also continuing. Further studies are required to support a US New Drug Application (NDA), however.
The open-label extension study (MAP US2) will assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing MAP US Phase III study and remain active with Crohn’s disease at week 26 — the primary endpoint of the MAP US study. Patients included in this study population will have the opportunity to receive further treatment until 52 weeks.
This extension study is considered to be a separate study, although data collected will be supplemental to the MAP US study data. Its primary endpoint is disease remission at week 16, defined as CDAI less than 150, and is planned to include 100 patients in 150 clinical sites across the US, Canada, Europe, Israel, Australia and New Zealand.
Further open-label studies with RHB-104 for Crohn’s disease are being planned by RedHill to provide additional supportive data for potential future marketing applications.
RedHill Biopharma is primarily focused on the development and commercialisation of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer.