On March 1, 2016 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, (Press release, RedHill Biopharma, MAR 1, 2016, View Source [SID:1234509323]) selected key research and development milestones and events anticipated in 2016. Schedule your 30 min Free 1stOncology Demo! RedHill’s pipeline includes several Phase III and Phase II-stage programs, as well as earlier-stage development programs. Selected potential highlights for 2016 include:
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RHB-104 – Crohn’s disease (Phase III) and multiple sclerosis (Phase IIa)
RedHill has completed enrollment of over half of the planned 270 patients in the Phase III MAP US study for Crohn’s disease in the U.S. and additional countries. Interim analysis of the MAP US study is expected in the second half of 2016, after half of the patients enrolled in the study complete 26 weeks of treatment. If approved for marketing, RHB-104 is expected to become a potential paradigm changer in the treatment of Crohn’s disease, targeting a worldwide market estimated to exceed $6 billion in 20171.
Interim top-line results from the CEASE-MS study, an open label Phase IIa, proof-of-concept clinical study exploring RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing-remitting multiple sclerosis (RRMS), are expected in the coming weeks.
RedHill and Quest Diagnostics (Q Squared Solutions LLC) continue to make progress with the development of the Mycobacterium avium subspecies paratuberculosis (MAP) companion diagnostic test following a pre-submission meeting held with the U.S. Food and Drug Administration (FDA) in 2015.
RHB-105 – H. pylori bacterial infection (Phase III)
A meeting with the FDA is scheduled for April 2016 to discuss the planned confirmatory Phase III study with RHB-105 in the U.S. for the treatment of H. pylori infection.
The FDA meeting follows positive top-line results from the ERADICATE Hp first Phase III study with RHB-105, conducted in the U.S., which successfully met its primary endpoint, demonstrating 89.4% efficacy in eradicating H. pylori with high statistical significance (p < 0.001). The Complete Study Report (CSR) is expected in the coming weeks.
The FDA has granted RHB-105 Qualified Infectious Disease Product (QIDP) designation under the GAIN Act, allowing for a total of eight years of market exclusivity, Fast-Track development and Priority Review status which shortens review time for future marketing applications. RHB-105 is targeting a potential worldwide market estimated at approximately $4.83 billion in 20152.
BEKINDA (RHB-102) – acute gastroenteritis (Phase III) and IBS-D (Phase II)
Top-line results from the GUARD Phase III study with BEKINDA 24 mg in the U.S. for acute gastroenteritis and gastritis are expected in the second half of 2016. If approved for marketing by the FDA, BEKINDA is expected to be the first-ever 5-HT3 antagonist drug indicated for acute gastroenteritis, targeting a potential worldwide market estimated to exceed $650 million annually3.
A Phase II study with BEKINDA 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) is planned to be initiated in the U.S. in the coming weeks, subject to regulatory clearance. The U.S. potential market for IBS-D treatments is estimated to exceed $1.3 billion by 20204.
RedHill is also pursuing potential marketing approval of BEKINDA in Europe for the oncology support indications of chemotherapy and radiotherapy-induced nausea and vomiting, pending additional discussions and feedback from European Member States as to whether additional clinical and CMC work is required.
YELIVA (ABC294640) – diffuse large B-cell lymphoma (Phase I/II), refractory or relapsed multiple myeloma (Phase I/II) and radioprotection (Phase II)
A Phase I/II clinical study was initiated to evaluate YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL). The study is being conducted at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans and is supported by a grant awarded to Apogee Biotechnology Corp. ("Apogee"), from which RedHill acquired the rights to YELIVA, from the NCI Small Business Technology Transfer (STTR) program, as well as additional support from RedHill.
A Phase I/II study with YELIVA for the treatment of refractory or relapsed multiple myeloma is planned to be initiated during the second quarter of 2016. The study will be conducted at Duke University Medical Center and is supported by a $2 million grant from the NCI Small Business Innovation Research Program (SBIR) awarded to Apogee in conjunction with Duke University, with additional support from RedHill.
A Phase II clinical study to evaluate YELIVA as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy is planned to be initiated in the U.S. during the second half of 2016, subject to regulatory and other conditions.
RedHill is pursuing additional oncology and gastrointestinal indications with YELIVA and plans to initiate additional clinical programs, subject to regulatory and other conditions.
MESUPRON and RP101 – orally-administered oncology drug candidates (Phase II-stage)
RP101 – Results from the ongoing pre-clinical studies conducted in collaboration with the Fraunhofer Institute for Cell Therapy and Immunology (IZI), are expected during the first half of 2016. The research collaboration tests RP101 in pre-clinical oncology models, including pancreatic cancer, in combination with standard-of-care chemotherapies, and is intended to support the existing Phase I and Phase II clinical data with RP101 and to assess the drug’s clinical development path.
MESUPRON – Nonclinical studies are currently ongoing and are intended to support the clinical data from previous Phase I and Phase II studies with MESUPRON.
RIZAPORT (RHB-103) – acute migraines
In 2015, the Federal Institute for Drugs and Medical Devices of Germany (BfArM) granted marketing authorization of RIZAPORT 5 mg and 10 mg under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State. RedHill and IntelGenx Corp. ("IntelGenx") continue to work together to obtain national-phase approvals of RIZAPORT in additional European DCP territories.
RedHill and IntelGenx also continue to work together to bring RIZAPORT to the U.S. market. The companies expect to re-submit the RIZAPORT New Drug Application (NDA) to the FDA and receive a new PDUFA (Prescription Drug User Fee) date in the fourth quarter of 2016.
Ebola virus disease – early stage, non-clinical development program
Following positive initial non-clinical studies, RedHill continues to advance its collaboration with a U.S. government agency to test the antiviral activity of its proprietary experimental combination therapy of orally-administered actives for the treatment of Ebola virus disease.