Israel-based biopharmaceutical company RedHill Biopharma recently released an update on the development of its drug pipeline, including a treatment for Crohn’s disease, and announced key milestones expected by the company for the upcoming period. RedHill specializes in developing and commercializing oral, small molecule drugs to treat inflammatory and gastrointestinal diseases such as gastrointestinal cancers.
RedHill is developing RHB-104 as a potential treatment for Crohn’s disease, multiple sclerosis and other inflammatory diseases and is planning on completing the interim analysis of its phase III study, entitled the MAP US study, by the second half of the next year. The 26-week study includes 270 patients and has as primary endpoint of disease remission at the end of the treatment.
The company is planning to enroll Crohn’s patients in about 120 clinical sites in the U.S., Canada, Israel, New Zealand, Australia and Europe to participate in the phase III MAP US study. RedHill has already submitted clinical trial applications to the European authorities and may initiate the second Phase III Crohn’s disease study on RHB-104, the MAP EU study, following the potential European regulatory clearance, which is expected during the third quarter of the year.
In addition, the U.S. Patent and Trademark Office (USPTO) has granted the company a notice of allowance, covering the investigational treatment until at least 2029. Yesterday, the company’s chief business officer Guy Goldberg also hosted a presentation at the Jefferies 2015 Global Healthcare Conference, addressing the latest progress in the development of their leading medical products.
RedHill is also working on BEKINDA (RHB-102) as a potential treatment for gastroenteritis and gastritis, as well as for chemotherapy and radiotherapy-induced nausea and vomiting. The GUARD study, a phase III study of BEKINDA in patients with acute gastroenteritis and gastritis, is currently underway in the U.S. and the results are scheduled for between the end of the year and the beginning of 2016. The company believes that these results will be useful in supporting the submission of marketing applications in the U.S. and Europe.
RedHill plans to meet with the U.S. Food and Drug Administration (FDA) within the following weeks, while European regulatory agencies have also granted a positive recommendation about the European Marketing Authorization Application (MAA) submitted by RedHill in December 2014. A phase IIa proof of concept study for a new undisclosed indication is being planned to be initiated during the second half of the year.
ABC294640 is being developed to treat multiple inflammatory-GI diseases and related oncology indications. The investigational therapy is a proprietary, first-in-class, orally administered, new chemical entity (NCE) sphingosine kinase-2 (SK2) inhibitor that was already studied in several pre-clinical studies with successful results, as well as in phase I studies enrolling patients suffering from advanced solid tumors.
The last treatment for IBD is a bowel cleanser pill, RHB-106. The global rights for the medical product were acquired by Salix Pharmaceuticals, Inc., following a license agreement signed in 2014 by the two companies. Last April Valeant Pharmaceuticals International, Inc. announced the completion of its acquisition of Salix, and Valeant is currently reviewing the RHB-106 program.
In addition to the IBD therapies, RedHill has also announced results from its studies to evaluate RHB-105 – for H. pylori bacterial infection, MESUPRON and RP101, both of them for pancreatic cancer and other solid tumors, RIZAPORT (RHB-103) for acute migraines, as well as released the latest updates on its early stage development program focused on the Ebola virus disease.