Nasdaq GlobeNewswire

RedHill Biopharma Announces Last Patient Enrolled in the Phase III Study with RHB-104 for Crohn's Disease

Del
  • Top-line results are expected to be announced in mid-2018
     
  • The Phase III study evaluating RHB-104 for Crohn's disease (MAP US study) is a randomized, double-blind, placebo-controlled study that is evaluating the safety and efficacy of RHB-104 in 331 subjects with moderately to severely active Crohn's disease
     
  • Worldwide sales of Crohn's disease therapies exceeded $7.6 billion in 2016
     
  • A pivotal Phase III study with RHB-104 for Nontuberculous Mycobacteria (NTM) infections, with Fast-Track development status, is planned to be initiated in H1/2018             

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 09, 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 drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the last patient has been enrolled in the Phase III study with RHB-104 for Crohn's disease (MAP US study). Top-line results are expected to be announced in mid-2018.

The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study evaluating the safety and efficacy of RHB-104 in subjects with moderately to severely active Crohn's disease (defined as Crohn's Disease Active Index (CDAI) between 220 and 450). The primary endpoint of the MAP US study is disease remission, defined as a reduction in CDAI to less than 150 at week 26. The study enrolled 331 patients across approximately 150 clinical sites in the U.S., Canada, Europe, Israel, Australia and New Zealand.

Two pre-planned independent Data and Safety Monitoring Board (DSMB) meetings have been held to review data from the MAP US study, in which unanimous recommendations were given to continue the study without any changes to the protocol, investigator's brochure, study conduct or informed consent form. At the first DSMB meeting, held in December 2016, safety data from the study was reviewed. At the second DSMB meeting, held in July 2017, safety and efficacy data from the first 222 subjects who had completed week 26 assessments of the study was reviewed. 

In addition, an open-label extension Phase III study (the MAP US2 study) continues to evaluate the safety and efficacy of RHB-104 in subjects who remain with active Crohn's disease (CDAI greater than or equal to 150) after 26 weeks of blinded study therapy in the ongoing Phase III MAP US study. These subjects have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label MAP US2 extension study. The data collected in the MAP US2 study will be supplemental to the MAP US study data. The MAP US2 study's primary endpoint is disease remission at week 16, defined as CDAI of less than 150. The MAP US2 study is planned to enroll approximately 50-70 subjects in the U.S., Canada, Europe, Israel and New Zealand. Additional open-label studies with RHB-104 for Crohn's disease are being planned to generate further supportive clinical data for potential future marketing applications.

Additional clinical studies are likely to be required to support a U.S. New Drug Application (NDA) for RHB-104. If the MAP US study results are positive, RedHill will meet with the U.S. Food and Drug Administration (FDA) and key opinion leaders to present the data package and discuss the preferred development path.

The worldwide sales of Crohn's disease therapies exceeded $7.6 billion in 20161.

In addition to the ongoing Phase III studies with RHB-104 for Crohn's disease, RedHill plans, subject to regulatory approvals, to initiate a pivotal Phase III study with RHB-104 for the treatment of nontuberculous mycobacteria (NTM) infections in the U.S. in the first half of 2018. RHB-104 was granted Qualified Infectious Disease Product (QIDP) status by the FDA for the treatment of NTM infections. QIDP designation allows for Fast-Track development status, Priority Review of an NDA, if filed, and an additional five years of U.S. market exclusivity on top of the standard exclusivity period or Orphan Designation exclusivity period, as applicable, for a total U.S. market exclusivity of 8-12 years.

The clinical studies with RHB-104 are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institute 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), with top-line results expected in mid-2018, 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. 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. A pivotal Phase III study with RHB-104 for NTM infections is planned to be initiated. 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), supporting additional studies.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty biopharmaceutical company, 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 three gastrointestinal products in the U.S., and its clinical-stage pipeline includes treatments for gastrointestinal indications, pancreatic cancer and acute migraines: Donnatal®  - a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; Esomeprazole Strontium  Delayed-Release Capsules 49.3 mg - a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions; 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 a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA®  (RHB-102) - a once-daily oral pill formulation of ondansetron with successful top-line results from a Phase III study in acute gastroenteritis and gastritis and successful top-line results from a Phase II study in 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 inflammatory gastrointestinal diseases and (vii) RIZAPORT® (RHB-103) - an oral thin-film formulation of rizatriptan for acute migraines, with a U.S. NDA resubmitted to the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).

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 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; (xii) estimates of the Company's expenses, future revenues capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other 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. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, 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

__________________

1 EvaluatePharma, estimated market for diagnosis and drug treatment of Crohn's disease, January 2017. 




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

SEMAFO Mourns Passing of Board Chairman Jean Lamarre23.11.2017 22:01Pressemelding

MONTREAL, Nov. 23, 2017 (GLOBE NEWSWIRE) -- SEMAFO (TSX:SMF) (OMX:SMF) announces with sadness the passing of Mr. Jean Lamarre, Chairman of the Board of Directors of the Corporation, on November 22, 2017 following a short illness. Mr. Lamarre joined the Corporation's Board of Directors in 1997 and was appointed Chairman of the Board in 2000, a position he held until his demise. "Jean made an indelible mark on SEMAFO, both in terms of his corporate governance expertise and his 45 years of experience in Africa," said President and CEO Benoit Desormeaux. "Over his 20-year tenure with SEMAFO, he brought unique insight, business acumen and leadership to the Corporation as it transitioned from an exploration company to a junior gold producer. He did this, always without compromising his values: the integrity of the Corporation, his deep love for Africa and its people, and his priority to SEMAFO's long-term sustainability. On behalf of SEMAFO's Board of Directors, management and employe

Premier to join industry leaders at BDA London forum23.11.2017 21:39Pressemelding

HAMILTON, Bermuda, Nov. 23, 2017 (GLOBE NEWSWIRE) -- Premier David Burt will join more than two-dozen Bermuda executives in a multi-industry forum being held in London next week to showcase the breadth of expertise and advantages offered by the island's global business market. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/78c5ac53-07f7-4dd8-83e0-753ea5b4c80b Organised by the Bermuda Business Development Agency (BDA), the one-day event Tuesday, November 28 at ME London has attracted over 200 registrants. It will feature top regulatory and industry leaders in moderated discussion panels covering re/insurance, captive insurance, insurance-linked securities, asset management, family offices, and trust and private-client business. A networking reception will wrap the event in the evening. "The government supports the Bermuda Business Development Agency in this awareness-raising event that offers such gre

Crown Bioscience and Data Sciences International (DSI) Partner to Advance Metabolic Disease Research Using an Implanted Telemetry Device for Long-Term Blood Glucose Monitoring23.11.2017 14:00Pressemelding

SANTA CLARA, Calif., Nov. 23, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE: ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation cardiovascular and metabolic disease research, announces the successful development of an enhanced method for preclinical obesity and type 2 diabetes studies in partnership with Data Sciences International (DSI). Crown Bioscience's clinically relevant models and DSI's HD-XG implantable glucose device combine to create a superior approach to preclinical metabolic disease research. Recently published work in the Journal of Endocrinological Investigation and Nature's Scientific Reports demonstrates the advantages of a new method using DSI's HD-XG implantable glucose device and Crown Bioscience's models of spontaneous and diet-induced diabetes. The HD-XG device allows for continuous, long-term measurement

Euroloan Opens New Market in Spain23.11.2017 11:10Pressemelding

Helsinki, Finland, 2017-11-23 11:10 CET (GLOBE NEWSWIRE) -- According to James Hickson, CEO of Euroloan Group, initiating services in the Spanish market is a key step in the expansion strategy of the Fintech group. “We have seen a growing demand for easy payment solutions in several markets, and the Spanish market in particular offers a massive opportunity for growth with Euroloan’s advanced payment and credit solutions. Merchants and Consumers appreciate our simple, fast and efficient services. It’s all about making their life easier. Consistent with our strategy, we have identified a number of partners to accelerate our market entry approach and expect to be providing our lending and merchant solutions by the end of the 1Q 2018” The Group is now present in five countries in Europe, including Finland, Sweden, Poland, Luxembourg and Spain. “Euroloan aims to open up several additional new markets”, says Tommi Lindfors, Chairman of the Board of Euroloan Group. “Spain is an importan

BDA partners with government to attract cryptocurrency23.11.2017 06:25Pressemelding

HAMILTON, Bermuda, Nov. 23, 2017 (GLOBE NEWSWIRE) -- The Bermuda Business Development Agency (BDA) will take a lead role in an initiative launched by the Bermuda government today to accelerate the establishment and growth of digital currency business on the island. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/457f43b9-d7bb-48f1-83e2-b856b33ebacc At a press conference held by Premier the Hon David Burt and National Security Minister the Hon Wayne Caines, the government announced the formation of a task force comprising two teams to advance Bermuda's regulatory environment as a destination for utility tokens, tokenised securities, cryptocurrencies, and coin offerings. BDA Consultant for Emerging Technologies John Narraway was named as chair of the Blockchain Business Development Working Group, while BDA Board member Lydia Dickens will chair the Blockchain Legal and Regulatory Working Group, of which

VistaJet Partners With Christie's for the Global Tour of The Collection of Peggy and David Rockefeller22.11.2017 11:39Pressemelding

The sale will be the most significant philanthropic auction ever presented LONDON, Nov. 22, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global private aviation company, announces today its worldwide sponsorship of the exhibition and tour of The Collection of Peggy and David Rockefeller, the most significant auction entirely dedicated to raising funds for philanthropic causes.  The sale, consisting of numerous categories, will be conducted by Christie's, the world's leading art business, and will include a highlights exhibition tour in Hong Kong, London, Los Angeles and New York. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c78fdce7-7651-42a8-a621-14088da2cc86 http://www.globenewswire.com/NewsRoom/AttachmentNg/33af2489-a9a8-4bbe-b5f7-78e4c1f29ca2 http://www.globenewswire.com/NewsRoom/AttachmentNg/a16c2

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

Besøk vårt presserom