Nasdaq GlobeNewswire

RedHill Biopharma Announces Publication Demonstrating Potential Efficacy of RHB-104 for Crohn's Disease Associated with MAP Infection

Del
  • The peer-reviewed article, authored by scientists from the University of Central Florida, concludes that the triple combination of the RHB-104 active components provides excellent synergistic activity in the inhibition of mycobacterial growth, potentially leading to a new and effective treatment for Crohn’s disease associated with Mycobacterium avium subspecies paratuberculosis (MAP) infection
     
  • RedHill is conducting a first Phase III clinical study with RHB-104 for Crohn’s disease (the MAP US study), with nearly 200 patients recruited out of a total of 270 planned, and interim data and safety monitoring board (DSMB) analysis expected in the second half of 2016
     
  • The development of RHB-104, a proprietary and potentially ground-breaking therapy with potent intracellular, anti-mycobacterial and anti-inflammatory properties, is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by MAP infection in susceptible patients            

            
TEL-AVIV, Israel, June 22, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today announced the publication of an article demonstrating the potential efficacy of RHB-104 for Crohn’s disease associated with Mycobacterium avium subspecies paratuberculosis (MAP) infection.

The article was published in the peer-reviewed journal Gut Pathogens and was authored by scientists from the University of Central Florida1 (UCF) College of Medicine’s Burnett School of Biomedical Sciences2.

RHB-104 is a proprietary and potentially groundbreaking oral antibiotic combination therapy with potent intracellular, anti-mycobacterial and anti-inflammatory properties, currently undergoing a first Phase III study for Crohn’s disease and a Phase IIa study for multiple sclerosis. The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by MAP infection in susceptible patients.

The article3, entitled “RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis” describes a pre-clinical study intended to determine the efficacy of the RHB-104 active components (the antibiotics clarithromycin, clofazimine and rifabutin) against MAP strains isolated from the blood, tissue and milk of Crohn’s disease patients. The researchers determined the minimum inhibitory concentrations of the active components, separately and in dual and triple combinations, against 16 MAP clinical strains and 19 other mycobacteria.

The results of the study demonstrated that the RHB-104 active components, in their individual concentrations or in dual combinations, were not as effective against all microorganisms, compared to the triple combination at minimum inhibitory concentrations level. The authors concluded that lower concentrations of the triple combination of RHB-104 active components provided synergistic anti-MAP growth activity compared to individual or dual combinations of the drugs and, consequently, administration of RHB-104 is considered favorable and should lead to tolerable dosage that is desirable for long-term treatment of Crohn’s disease.

Dror Ben-Asher, RedHill’s CEO, said: “I would like to thank the scientists at the University of Central Florida in Orlando for this article which supports the continued development of RHB-104 for Crohn’s disease. RHB-104 is one of RedHill’s flagship gastrointestinal programs and is currently undergoing a Phase III study, named the MAP US study, in the U.S. and additional countries. With nearly 200 patients recruited out of a total of 270 planned, the MAP US Phase III study is advancing well and we expect interim data and safety monitoring board (DSMB) analysis during the second half of 2016. The final results from the Phase IIa proof-of-concept study with RHB-104 in multiple sclerosis are also expected in the second half of 2016, following our previous announcement of encouraging preliminary data in March 2016.”

Dr. Reza Fathi, Ph.D., RedHill’s Senior VP R&D, added: “We are pleased with the important findings described in this article which provide further validation of the synergistic activity and potential efficacy of RHB-104 in eradicating Mycobacterium avium subspecies paratuberculosis, or MAP, - a suspected etiological agent of Crohn’s disease and possibly additional autoimmune, inflammatory and mycobacterial diseases. The results from this study suggest that RHB-104, if approved, could become a new and effective therapy for the treatment of Crohn’s disease.” 

RHB-104 is currently undergoing a first Phase III study for Crohn’s disease in the U.S., Canada, Israel, Australia and additional countries (the MAP US study). Interim analysis of the ongoing randomized, double-blind, placebo-controlled MAP US study is expected in the second half of 2016, after half of the 270 patients planned to be enrolled in the study will have completed 26 weeks of treatment.

RHB-104 is also being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS). The open label Phase IIa, proof-of-concept clinical study is evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for RRMS (the CEASE-MS study). RedHill announced encouraging top-line interim results from this study in March 2016. Final results of the completed 48-week study are expected during the second half of 2016. 

The MAP US Phase III study and the CEASE-MS Phase IIa study are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

About RHB-104:
Currently in a first Phase III study for the treatment of Crohn’s disease (the MAP US study) and a second Phase III study which is being prepared (the MAP EU study), RHB-104 is a proprietary and potentially groundbreaking oral antibiotic combination therapy, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study. RHB-104 is covered by several issued and pending patents. RedHill is also conducting the CEASE-MS Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing-remitting multiple sclerosis (RRMS), with top-line interim results announced.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases and cancer. RedHill’s current pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA(RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA (ABC294640)  a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON® - a Phase II-stage first-in-class uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumors; (vii) RP101 -currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii)RIZAPORT (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015; and (ix) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company's business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

1 The University of Central Florida provides laboratory provides services as a sub-contractor as part of RedHill’s MAP US Phase III study with RHB-104.

2 RedHill announced in September 2011 that it had acquired an exclusive license from the University of Central Florida to a patent-protected diagnostic test for the detection of MAP.

3 Alcedo KP, Thanigachalam S, Naser SA. RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis, Gut Pathogens, 2016, 8:32.

         Company contact:
         Adi Frish
         Senior VP Business Development &
         Licensing
         RedHill Biopharma
         +972-54-6543-112
         adi@redhillbio.com
         
         IR contact (U.S.):
         Marcy Nanus
         Senior Vice President
         The Trout Group
         +1-646-378-2927
         Mnanus@troutgroup.com

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

ERYTECH Pharma Reports Voting Results from Annual General Meeting Held on June 28, 201817.7.2018 22:30Pressemelding

LYON, France and CAMBRIDGE, Mass., July 17, 2018 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP) announced that its 2018 Annual General Meeting was held in Lyon on Thursday, June 28, 2018. At the meeting, all resolutions for which management recommended a vote in favor, were adopted, including: - Approval of the annual financial statements and consolidated financial statements for the year ended December 31, 2017 and quietus of directors; - Allocation of the financial year's results; - Approval of regulatory agreements and commitments referred to in Article L.225-38 of the French Commercial Code; - Approval of the regulations of the share subscription and/or purchase options plan adopted by the Board of Directors on June 27, 2017; - Authorization for the Board of Directors to grant share subscription and/or share purchase options and/or to issue detachable share subscription warrants to corporate officers and employees of the Company or companies in the ERYTECH Pharma

Williams Scotsman Receives Competition Bureau Clearance for ModSpace Acquisition17.7.2018 22:15Pressemelding

BALTIMORE, July 17, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (NASDAQ:WSC) ("Williams Scotsman"), a specialty rental services market leader providing innovative modular space and portable storage solutions across North America, today announced that, on July 16, 2018, the Canadian Competition Bureau issued a No Action Letter relating to Williams Scotsman's proposed acquisition of Modular Space Corporation ("ModSpace"). WillScot has now obtained the regulatory approvals required to complete the acquisition and continues to progress towards closing in the third quarter of 2018. About Williams Scotsman Headquartered in Baltimore, Maryland, WillScot Corporation is the public holding company for the Williams Scotsman family of companies in the United States, Canada and Mexico. WillScot Corporation trades on the NASDAQ stock exchange under the ticker symbol "WSC." Williams Scotsman is a specialty rental services market leader providing innovative modular space and portable storage solutio

Minerva Neurosciences Elects Jeryl Hilleman to Board of Directors17.7.2018 22:05Pressemelding

WALTHAM, Mass., July 17, 2018 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced the election of Jeryl Hilleman to the Board of Directors of the Company. "Jeri brings a broad life sciences background to Minerva that includes high growth commercial biopharma, med-tech and data science companies," said William F. Doyle, Lead Independent Director of Minerva. "Her track record of delivering strategic and financial growth through execution, strategic partnering and multiple acquisitions will serve Minerva well as the Company completes five ongoing late-stage clinical trials with roluperidone, seltorexant and MIN-117." Ms. Hilleman is presently Chief Financial Officer of Intersect ENT (NASDAQ:XENT), a medical device company with commercial products for the treatment of chronic sinusitis. Previously, she served as CFO of several public

Orion Biotechnology Awarded a $2M Grant from National Center for Research and Development to Fund Further Development of its HIV Microbicide17.7.2018 21:00Pressemelding

OTTAWA, July 17, 2018 (GLOBE NEWSWIRE) -- Orion Biotechnology Canada Ltd., a developer of novel medical treatments, today announced that its European subsidiary, Orion Biotechnology Polska Sp. z o.o., was awarded a grant of $2M US dollars by the National Center for Research and Development . The grant will fund a project to advance development of the company's innovative microbicide candidate (OB-002H). Designed to prevent the transmission of HIV, OB-002H has the potential to address an urgent and growing need for an HIV prevention product that is affordable, appealing to use, and easily integrates into the lifestyles of people at risk for HIV infection regardless of age, sex or gender. The project is co-financed by the National Center for Research and Development under the InnoNeuroPharm program - Measure 1.2: Sectoral R & D programs of the Intelligent Development Operational Program 2014-2020. Orion Biotechnology will use the grant to complete IND enabling studies, advance OB-002H to

Greater Anglia Selects PowerPlan to Optimise Its Asset Investments17.7.2018 15:29Pressemelding

ATLANTA, July 17, 2018 (GLOBE NEWSWIRE) -- Greater Anglia, a UK-based train operating company, has selected PowerPlan's Asset Investment Optimization software suite to maximise its asset investments over a 40-year time period. Greater Anglia's long-term investment strategy includes a 40-year asset plan to meet its regulatory requirements. For what was historically built with manual processes and not easily tracked, the Asset Investment Optimization solution from PowerPlan will provide a comprehensive, auditable approach to help the company analyze different investment scenarios for impacts to risk, cost, timing and level of service and provide a defendable asset plan for the next four decades. "The condition of our assets drives our business," said Richard Turner, Head of Asset Management for Greater Anglia. "With PowerPlan, we can apply a fact-based methodology to prioritise investments, maximise their return and produce plans that communicate our asset strategy to internal and extern

Oxford Immunotec Schedules Second Quarter 2018 Earnings Release and Conference Call for July 31, 201817.7.2018 14:30Pressemelding

OXFORD, United Kingdom and MARLBOROUGH, Mass., July 17, 2018 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company, today announced that it plans to release second quarter 2018 financial results prior to market open on Tuesday, July 31, 2018. Dr. Peter Wrighton-Smith, Chief Executive Officer, and Rick Altieri, Chief Financial Officer, will host a conference call to review the Company's results at 8:00 a.m. Eastern Time the same day. The call will be concurrently webcast. To listen to the conference call on your telephone, please dial (855) 363-5047 for United States callers or +1 (484) 365-2897 for international callers and reference confirmation code 9268558, approximately ten minutes prior to start time. To access the live audio webcast or subsequent archived recording, visit the Investor Relations section of Oxford Immunotec's website at www.oxfordimmunotec.com. The replay will be available on the Company's website for approximately

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom