Nasdaq GlobeNewswire

RedHill Biopharma Announces Unanimous Positive DSMB Recommendation for Continuation of the Phase III Study with RHB-104 for Crohn's Disease

Del
  • The independent Data and Safety Monitoring Board (DSMB) reviewed safety and efficacy data, of which RedHill remains blinded, from the first 222 subjects who have completed week 26 assessments in the Phase III MAP US study
     
  • To date, over 300 of the planned 410 subjects, have been randomized in the Phase III MAP US study
     
  • An open-label extension Phase III study (the MAP US2 study) is ongoing in parallel in patients who remain out of remission after 26 weeks of blinded study therapy in the MAP US study

TEL-AVIV, Israel and RALEIGH, N.C., July 31, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported, following a second pre-planned meeting to assess the safety and efficacy data from its ongoing first Phase III study with RHB-104 for Crohn's disease (the MAP US study) by an independent Data and Safety Monitoring Board (DSMB), that it has received a unanimous positive recommendation from the DSMB to continue the study as planned.

The independent DSMB reviewed safety and efficacy data, of which RedHill remains blinded, from the first 222 subjects who have completed week 26 assessments in the Phase III MAP US study. In December 2016, a first pre-planned independent DSMB meeting reviewed safety data from the MAP US study and provided a unanimous recommendation to continue the study as planned.

Ira  Kalfus, MD, Medical Director at RedHill , said: "RHB-104 is a potentially ground-breaking new therapy for Crohn's disease. The DSMB has reviewed the unblinded interim safety and activity results of the Phase III MAP US study, and we are very encouraged by its unanimous recommendation to continue the study through randomization of all planned 410 subjects, with no changes to the protocol, investigator's brochure, study conduct or informed consent form. We continue to enroll subjects and expect to complete enrollment in the study in the first half of 2018. I would like to thank the DSMB members for their professional and independent assessment of the study data and for their positive recommendation."

RHB-104 is a proprietary, orally-administered, potentially ground-breaking, antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties, targeting a suspected underlying bacterial infectious cause of Crohn's disease, Mycobacterium avium subspecies paratuberculosis (MAP).

The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study evaluating the safety and efficacy of RHB-104 in patients with moderately to severely active Crohn's disease (defined as CDAI between 220 and 450). The MAP US study is being conducted in up to 150 clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand. Additional clinical data will need to be generated to support a U.S. New Drug Application (NDA) for RHB-104. The primary endpoint of the MAP US study is disease remission, defined as a reduction in Crohn's Disease Activity Index (CDAI) to less than 150 at week 26.

To date, over 300 of the planned 410 subjects, have been randomized in the MAP US study. A third, safety-focused, independent DSMB meeting is expected to be held when 75% of the planned 410 subjects have completed 26 weeks of study participation. Completion of recruitment for the MAP US study is expected in the first half of 2018.

Additionally, an open-label extension Phase III study (the MAP US2 study) is ongoing to further assess the safety and efficacy of RHB-104 in patients who remain out of remission (CDAI greater than or equal to 150) after 26 weeks of blinded study therapy in the ongoing Phase III MAP US study.

The clinical studies with RHB-104 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), RHB-104 is a proprietary, orally-administered, potentially ground-breaking oral antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn's disease is related to Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by Pharmacia/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. Additionally, an open-label extension Phase III study (the MAP US2 study) is ongoing to assess the safety and efficacy of RHB-104 in subjects who have completed week 26 assessments in the ongoing Phase III MAP US study and remain with active Crohn's disease (CDAI greater than or equal to 150) at week 26. RHB-104 is covered by several issued and pending patents. RedHill also completed a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in subjects treated for relapsing-remitting multiple sclerosis (the CEASE MS study), with top-line final results suggesting meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development. RHB-104 was granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of nontuberculous mycobacteria (NTM) infections, providing a Fast-Track development pathway, as well as NDA Priority Review and an additional five years of U.S. market exclusivity, if approved. RedHill is in discussions with the FDA regarding the development of RHB-104 development program for NTM infections.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty 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 gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. - Donnatal® , a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam® , a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill's clinical-stage pipeline includes: (i) TALICIA(TM) (RHB -105) - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104 -an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis, and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA®  (RHB-102) - a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study 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, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) 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 two EU member states under the European Decentralized Procedure (DCP). More information about the Company is available at: www.redhillbio.com.

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 successfully market Donnatal® and EnteraGam®, (vi) the Company's ability to establish and maintain corporate collaborations; (vii) 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; (viii) 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; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) 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; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company's expenses, future revenues capital requirements and the Company's needs for additional financing; (xiii) the Company's Expanded Access Program, which allows patients with life-threatening diseases potential access, subject to regulatory and other approvals, to RedHill's investigational new drugs that have not yet received regulatory marketing approval, if a patient suffers an adverse experience using such investigative drug, potentially adversely affecting the clinical development program of that investigational product or the Company generally; (xiv) competitive companies and technologies within the Company's industry. 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 23, 2017. 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.

 

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



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: RedHill Biopharma Ltd. via Globenewswire

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

Cisco 2018 Annual Cybersecurity Report Reveals Security Leaders Rely on and Invest in Automation, Machine Learning and Artificial Intelligence to Defend Against Threats21.2.2018 14:00Pressemelding

Findings show 39 percent of organizations are reliant on automation, 34 percent are reliant on machine learning, 32 percent are highly reliant on AI SAN JOSE, Calif., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Malware sophistication is increasing as adversaries begin to weaponize cloud services and evade detection through encryption, used as a tool to conceal command-and-control activity. To reduce adversaries' time to operate, security professionals said they will increasingly leverage and spend more on tools that use AI and machine learning, reported in the 11th Cisco® 2018 Annual Cybersecurity Report (ACR). While encryption is meant to enhance security, the expanded volume of encrypted web traffic (50 percent as of October 2017) - both legitimate and malicious - has created more challenges for defenders trying to identify and monitor potential threats. Cisco threat researchers observed more than a threefold increase in encrypted network communication used by inspected malware samples over a

Appian Corporation : Banco Santander Selects Appian21.2.2018 13:30Pressemelding

RESTON, Va., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Appian (NASDAQ:APPN), a leading low-code and business process management platform provider, today announced that it has signed a global agreement with Banco Santander (SAN SM, STD US, BNC LN). Banco Santander, the largest bank in the Eurozone by market capitalization, will leverage Appian's platform in the cloud for enterprise process improvement. Banco Santander is a leader in retail and commercial banking, and has a meaningful market share in 10 core countries in Europe and the Americas. Appian has been chosen because it provides a comprehensive platform for Business Process Management (BPM) and Case Management in a digital environment, and the ability to deploy applications through fast and simple low-code development. Appian Cloud has an extensive collection of security accreditations, making it a highly trusted platform for rapid application development. Appian is accredited for HIPAA, SOC 2 and SOC 3, The PCI Data Security Standard,

Apricus Biosciences Announces Corporate Update, Fourth Quarter and Full Year 2017 Financial Results Conference Call21.2.2018 13:00Pressemelding

SAN DIEGO, Feb. 21, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the Company's fourth quarter and full year 2017 financial results will be released on Thursday, March 1, 2018 at 4:01 p.m. Eastern Time. Company management will host a conference call on Thursday, March 1, 2018, at 4:30 p.m. Eastern Time to discuss the financial results and its plans for addressing the Vitaros Complete Response with the FDA. To participate by telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867 (International). The conference ID number is 3687726. The live audio webcast can be accessed via the Investor Relations' section of the Company's website at www.apricusbio.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for 30 days following the live call. About Apricus Biosciences, Inc

Purepoint Uranium Acquires Strategic Land Positions in the Athabasca Basin, Saskatchewan21.2.2018 12:45Pressemelding

TORONTO, Feb. 21, 2018 (GLOBE NEWSWIRE) -- Purepoint Uranium Group Inc. (the "Company" or "Purepoint") (TSX.V:PTU) today reported that since October, 2017 it has acquired through staking an additional 52,479 hectares of mineral claims in the Athabasca Basin, Saskatchewan Canada representing a substantial increase in the Company's 100% owned projects. "We have taken a very precise and strategic approach to our staking - focusing on the enlargement of our existing projects or securing highly prospective areas of defined potential," said Chris Frostad, President & CEO at Purepoint. "Over the past four months we have successfully added three new projects, enlarged two existing projects and nearly doubled our 100% owned land position". "Much of our new ground lies on the SW edge of the Athabasca Basin, proximal to our Smart Lake Project. Our initial drilling at Smart Lake identified a radioactive shear that was associated with intense alteration," said Scott Frostad, Vice President Explorat

Aurora Releases Third Quarter Results20.2.2018 21:08Pressemelding

Aurora Solar Technologies Inc. / Aurora Releases Third Quarter Results . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. NORTH VANCOUVER, British Columbia, Feb. 20, 2018 (GLOBE NEWSWIRE) -- Aurora Solar Technologies Inc. ("Aurora")("Company") (TSX.V:ACU) (OTCBB:AACTF) (FSE:A82), a leader in inline measurement and control technology for the photovoltaic manufacturing industry, released today its third quarter results. Revenue for the quarter was $337,325, gross margin was 62.9%, resulting in an operating income loss of ($398,959). Year-to-date for nine months, the Company has recognized $1,903,020 in revenue, an increase of 238% over the same period last year. The operating income (loss) year to date was ($674,983), a reduction of 67.7% from the same period last fiscal year. The Company also confirms, excluding new potential orders, that it has unrecognized revenue from shipments and order backlog of approxi

Bermuda Principles event merges science and business20.2.2018 16:36Pressemelding

HAMILTON, Bermuda, Feb. 20, 2018 (GLOBE NEWSWIRE) -- Scientists and researchers from around the world are gathering in Bermuda this week for the second edition of a conference exploring the field of genetic research. Premier the Hon David Burt will officially open "Bermuda Principles: Impact on Splicing" Wednesday evening at the Fairmont Southampton. The conference, which runs through Saturday, has registered 50 delegates, along with an impressive roster of 36 speakers and panellists from 11 countries, including Australia, Denmark, Switzerland and South Africa. Among the attendees are prominent geneticists, scientists, professors, researchers, PhD students working in international labs, biotech representatives and investors. "I am elated to see the growth of the conference since last year's event," said Bermudian Dr. Carika Weldon, a biomedical researcher with her own lab at De Montfort University, UK, who conceived of the event and launched it last February. "My main aim has been to p

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

Besøk vårt presserom