- The confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to enroll 440 patients in up to 55 U.S. sites, is planned to be initiated by April 2017 following completion of an ongoing supportive pharmacokinetic (PK) program.
- 254 of the planned total of 410 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled first Phase III study in the U.S. and additional countries with RHB-104 for Crohn's disease (the MAP US study).
- A second independent data and safety monitoring board (DSMB) meeting of the MAP US study is expected in the second quarter of 2017, with an interim efficacy analysis and an option for early stop for success for overwhelming efficacy.
- 291 of the planned total of 320 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA ® 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study). Top-line results are expected by mid-2017.
- 83 of the planned total of 120 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase II clinical study with BEKINDA ® 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results are expected in mid-2017.
- RedHill is currently pursuing several Phase I/II clinical studies with YELIVA ® in the U.S., targeting oncology indications, with support from National Cancer Institute (NCI) grants awarded to Apogee Biotechnology and U.S. universities, including ongoing studies for advanced hepatocellular carcinoma (Medical University of South Carolina), refractory or relapsed multiple myeloma (Duke University Medical Center) and refractory/relapsed diffuse large B-cell lymphoma and Kaposi sarcoma (Louisiana State University Health Sciences Center).
- Additional Phase I/II studies with YELIVA ® are in various stages of preparation, including a Phase Ib study to evaluate YELIVA ® as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy, planned to be initiated in the first half of 2017.
- As part of RedHill's strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with a commercial presence in the U.S., the Company entered earlier this month into an exclusive co-promotion agreement with a subsidiary 2 of Concordia International Corp. (NASDAQ:CXRX) (TSX:CXR), granting RedHill certain U.S. promotion rights for Donnatal ®, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel) 3. RedHill expects to initiate promotion of Donnatal ® in the coming months.
- Re-submission of the RIZAPORT ® NDA to the FDA is expected in the first half of 2017. RIZAPORT ® was approved for marketing in Germany under the European Decentralized Procedure (DCP) in October 2015 and a first commercialization agreement was signed with Grupo JUSTE S.A.Q.F for Spain and a second commercialization agreement was signed with Pharmatronic Co. for South Korea. RedHill continues discussions with additional potential commercialization partners for RIZAPORT ® in the U.S., Europe and other territories.
Company contact:Adi FrishSenior VP Business Development &LicensingRedHill Biopharmafirstname.lastname@example.orgIR contact (U.S.):Marcy NanusSenior Vice PresidentThe Trout Group+1-646-378-2927Mnanus@troutgroup.com