RedHill Biopharma Commences Patient Screening in a Phase IIa Clinical Trial With RHB-104 for Multiple Sclerosis

  • The open label Phase IIa study is designed to assess the efficacy and safety of RHB-104 in Multiple Sclerosis (MS) patients. The study follows successful completion of 4 pre-clinical studies
  • A first Phase III clinical trial with RHB-104 for Crohn's disease (the "MAP US Study") is planned to commence by the third quarter of 2013. Recruitment of sites in the U.S., Canada and Israel is underway

TEL-AVIV, Israel, June 5, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, announced that patient screening has commenced in the Phase IIa, proof of concept, clinical study (the "CEASE-MS Study"), to assess the efficacy and safety of fixed dose combination RHB-104, a patent protected combination therapy of three antibiotics in a single capsule, as an add-on therapy to interferon beta-1a in patients treated for Relapsing Remitting Multiple Sclerosis ("RRMS").

The phase IIa CEASE-MS Study follows the successful completion of four pre-clinical studies with RHB-104.

Sixteen patients with RRMS are expected to participate in the open label Phase IIa CEASE-MS Study, which will be conducted at two medical centers in Israel. The study is designed to assess the efficacy and safety of RHB-104 in RRMS patients after 24 weeks of treatment, with the primary endpoint being the number of combined unique active lesions after treatment as compared to baseline. Patients will be followed-up for an additional term of 24 weeks after completing treatment with RHB-104. Secondary endpoints will include changes in pro-inflammatory cytokine markers, Mycobacterium avium subsp. paratuberculosis (MAP) status, relapse rate, Expanded Disability Status Scale (EDSS) and safety and tolerability of RHB-104.

"We are very pleased that this important Phase IIa Multiple Sclerosis study is now underway," said Clara Fehrmann, RedHill's RHB-104 MS Product Manager. "There is an increasing awareness in the medical community to the possibility that a bacterial induced dysregulated immune system plays a critical role in the pathogenesis of MS. It is RedHill's hope that the CEASE-MS Study will demonstrate RHB-104's potential to become an effective treatment option for patients with MS."

Dr. Radi Shahien of Ziv Medical Center, Principal Investigator of the CEASE-MS Study added: "The MAP bacterium has been identified as a pathogen that may contribute to the development of MS. The CEASE-MS Study with RHB-104 aims to test this new hypothesis to the etiology of MS. RHB-104 has the potential to improve the lives of people with MS, and I am excited to be leading this important study."

Multiple Sclerosis is an inflammatory, demyelinating, and neurodegenerative disease of the central nervous system of uncertain etiology that exhibits characteristics of both infectious and autoimmune pathology. RHB-104 is a multifaceted drug that in addition to bactericidal properties against intracellular infections, has potentially distinct mechanisms of action that include both anti-inflammation and neuroprotection. The worldwide sales of MS therapies are estimated to have exceeded $14 billion USD in 20121.

RHB-104 is also being evaluated for the treatment of Crohn's disease. The Company is planning to commence a first Phase III clinical trial (named "MAP US Study") for this indication by the third quarter of 2013, with recruitment of sites in the U.S., Canada and Israel underway.

The Company also plans to commence a Phase II/III clinical trial with RHB-105 (H. Pylori) in the third quarter of 2013.

RedHill has recently submitted its first U.S. New Drug Application ("NDA") for RHB-103 (migraine), and plans to submit a second U.S. NDA, for RHB-102 (oncology support anti-emetic), by the first half of 2014.

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent protected, new formulations and combinations of existing drugs. The Company's current product pipeline includes: (i) RHB-101 - a once-daily formulation of a leading congestive heart failure and high blood pressure drug, with NDA planned to be submitted subject to further CMC and PK work, and Marketing Authorization Application (MAA) in Europe planned to be submitted subject to further CMC work, (ii) RHB-102 - a once-daily formulation of a leading chemotherapy and radiotherapy-induced nausea and vomiting prevention drug, planned for U.S. NDA submission in the first half of 2014, (iii) RHB-103 - an oral thin film formulation drug for the treatment of acute migraine, with a U.S. NDA submitted March 2013, (iv) RHB-104 - a combination therapy for the treatment of Crohn's disease, planned to commence a first Phase III trial by the third quarter of 2013, as well as Multiple Sclerosis (MS) Phase IIa proof of concept trial currently underway, (v) RHB-105 - a combination therapy for the treatment of ulcer causing Helicobacter pylori infection, planned to commence a phase II/III trial by the third quarter of 2013, and (vi) RHB-106 - an encapsulated formulation for bowel preparation (laxative) ahead of colonoscopy. For more information please visit:

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1 EvaluatePharma - 2013 worldwide sales by indication

CONTACT: PR contact (US): Lauren Glaser Vice President The Trout Group +1-646-378-2972 Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 adi@redhillbio.comSource:RedHill Biopharma Ltd.