RedHill Biopharma Reports Successful Final Results of Phase III Study With RHB-105 for H. pylori Infection
The RHB-105 first Phase III Clinical Study Report demonstrates the efficacy and safety of RHB-105 in eradication ofH. pylori infection, supports the potential superior efficacy of RHB-105 over current standard-of-care therapies and confirms the positive top-line results previously announced
A meeting with the FDA is scheduled for April 2016 to discuss the confirmatory Phase III study with RHB-105, planned to be initiated in Q3/2016, and the path for approval of RHB-105 as a potential best-in-class, first-line therapy for H. pylori infection
RHB-105 has received FDA QIDP designation under the GAIN Act, including Fast-Track development, Priority Review and extended market exclusivity for a total of eight years
The 2015 global and U.S. market potential for H. pylori eradication therapies were estimated at approximately $4.83 billion and $1.45 billion, respectively
TEL-AVIV, Israel, March 08, 2016 (GLOBE NEWSWIRE) -- 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, today announced successful final results from the first Phase III clinical study with RHB-105 for the eradication of H. pylori (the ERADICATE Hp study).
The Phase III Clinical Study Report (CSR) confirms the positive top-line results previously announced by the Company. The study successfully met its primary endpoint of superiority over historical standard-of-care (SoC) eradication rate levels of 70%, with high statistical significance (p<0.001). The final results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105 in all patients who received at least one dose of randomized study treatment and underwent a 13C UBT test of cure at Visit 4, 28-35 days after completion of treatment with RHB-105. Subsequent open-label treatment of patients in the placebo arm with SoC therapy for persistent H. pylori infection demonstrated a 63% eradication rate with SoC, further supporting the potential superior efficacy of RHB-105 over SoC.
The safety profile of RHB-105 was consistent with that observed in the top-line analysis of the Phase III study. RHB-105 was shown to be safe and well-tolerated, with the majority of treatment-related adverse events assessed as mild to moderate. Only one serious adverse event was recorded in the RHB-105 treatment group and was assessed as unrelated to the study drug. The adverse event profile, laboratory values, and other safety assessments did not indicate safety concerns with respect to the use of RHB-105 in the study patient population. Pharmacokinetics samples were collected during the study and a stand-alone PK report will be generated when data analysis is complete.
A meeting with the FDA is scheduled for April 2016 to discuss the planned confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection. RedHill intends to initiate the confirmatory Phase III study in the third quarter of 2016, subject to regulatory and other approvals.
The randomized, placebo-controlled, ERADICATE Hp Phase III study was intended to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori bacterial infection. A total of 118 non-investigated dyspepsia patients with confirmed H. pylori infection were enrolled and treated in the study, which was conducted in the U.S. Subjects were randomized in a 2:1 ratio to receive either RHB-105 or a placebo for a period of 14 days and assessed for the eradication of H. pylori infection. Subsequent to completion of the treatment period and the un-blinding of the study, subjects enrolled in the placebo arm were entitled to receive SoC therapy as prescribed by the treating physician in an open-label setting, and were assessed for the eradication of H. pylori infection 28-35 days after completion of treatment. David Graham, M.D., M.A.C.G., of the Baylor College of Medicine, a key opinion leader in the field of gastric cancer and H. pylori infection, served as Principal Investigator of the ERADICATE Hp Phase III study.
Gilead Raday, RedHill’s Senior VP Corporate and Product Development, said: “We are very pleased that the final results from the successful first Phase III study with RHB-105 for H. pylori eradication confirmed the positive top-line results previously announced. The final results further support the potential superior efficacy of RHB-105 over current standard-of-care therapies for H. pylori and showed RHB-105 to be safe and well-tolerated. We look forward to meeting with the FDA in April to present the Clinical Study Report and discuss the path to potential approval and the intended design for the confirmatory Phase III study with RHB-105, which we plan to initiate during the third quarter of the year. We continue to work diligently to bring RHB-105 to the market as soon as possible as a best-in-class, first-line therapy for eradication of H. pylori.”
RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as Priority Review status, potentially leading to a shorter review time by the FDA of a New Drug Application (NDA), if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity, in addition to the standard exclusivity period, for a total of 8 years of market exclusivity.
The 2015 global and U.S. market potential for H. pylori eradication therapies, at current branded prices, were recently estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication1.
With RHB-105, RedHill is pursuing an indication of first-line treatment of H. pylori infection, regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori, which are typically indicated only for patients with active or recent history of duodenal ulcer disease. If approved, RHB-105 may be the first H. pylori eradication therapy to target this broader indication, which would significantly expand the potential patient population for this drug candidate.
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for the treatment of H. pylori infection. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. A first Phase III study with RHB-105 was completed in the U.S. with positive results (the ERADICATE Hp study). The study demonstrated an overall success rate of 89.4% in eradicating H. pylori, and met its protocol-defined primary endpoint of superiority in eradication of H. pylori infection over historical standard of care efficacy levels of 70%, with high statistical significance (p<0.001). RedHill plans to conduct a confirmatory Phase III study. Additional studies may be required, subject to FDA feedback. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as Priority Review status, potentially leading to a shorter review time by the FDA of an NDA, if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity, in addition to the standard exclusivity period, for a total of 8 years of market exclusivity.
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, including 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 a planned Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA™ (ABC294640) - an orally-administered first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications with a Phase I/II study initiated for refractory/relapsed diffuse large B-cell lymphoma (DLBCL); (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 SECon 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 Jerry Rosenblatt, Ph.D., a member of RedHill’s Advisory Board and Partner at Foster Rosenblatt, RedHill Biopharma press release: RedHill Biopharma’s Investor Webcast Forum Provides Update on the RHB-105 Phase III Program and Potential H. Pylori Eradication Market, May 18, 2015.
Senior VP Business Development &
IR contact (U.S.):
Senior Vice President
The Trout Group
Om 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
Barings Alternative Investments Expands Aviation Investment Platform Through Partnership with Genesis Aircraft Services23.3.2018 15:00 | Pressemelding
CHARLOTTE, N.C., March 23, 2018 (GLOBE NEWSWIRE) -- Barings Alternative Investments, part of Barings LLC, one of the world's leading financial services firms, announced today the expansion of its aircraft leasing platform on behalf of the firm's institutional fund clients through Genesis Aircraft Services Limited. To facilitate new aircraft acquisitions on behalf of Barings' clients, Genesis will increase existing capabilities to now include all commercial, technical, portfolio and legal management functions required of a full-service premier owner and lessor of commercial aircraft. As part of its increased capabilities, Karl Griffin will join Genesis as Chief Commercial & Investment Officer and will also be appointed to the Genesis Board of Directors effective May 2018; Anna Reimers will join Genesis as Chief Legal Officer; and John McMahon will be appointed to Genesis' Board as an independent director. Griffin is currently the Chief Operating Officer at DAE Capital, an aircraft leasi
Agrisolutions Acquires Trinity23.3.2018 12:00 | Pressemelding
HAMILTON, Ontario, March 23, 2018 (GLOBE NEWSWIRE) -- Venanpri Group's Agrisolutions division, which services the global agricultural marketplace with its Ingersoll and Bellota brands, announced today the acquisition of Trinity Logistics Corporation ("Trinity"). Based in the U.S., Trinity provides supply-chain solutions relating to fasteners and other components to leading global OEMs that produce mission critical machinery for the agricultural and construction end markets. The terms of the transaction were not disclosed. Headquartered in Davenport, Iowa, Trinity has established ten strategically located service facilities throughout the United States. Trinity specializes in the supply of standard and custom components through vendor managed inventory programs and other arrangements tailored to customer needs. Trinity utilizes its industry leading technology to improve the flow of products, services and information across the supply chain resulting in excellence in the operations of it
Comodo CA Sees 35 Percent Year-Over-Year Increase in EV Certificates22.3.2018 15:47 | Pressemelding
EV SSL will be a topic of discussion at the Comodo CA booth during RSA 2018 CLIFTON, N.J., March 22, 2018 (GLOBE NEWSWIRE) -- Comodo CA, a worldwide leader in digital identity solutions, will address evolving cyberthreats and the increasing importance Extended Validation (EV) TLS/SSL certificates play in securing websites and inspiring consumer trust at the RSA Conference 2018, San Francisco, April 16 - 20. According to the Feb 2018 Netcraft report, Comodo CA has seen a 35 percent year-over-year increase of EV certificate units* making it one of the fastest growing providers of high assurance certificates. The volume of EV certificates globally also saw a record year in 2017 as more and more businesses adopt EV as standard practice for their websites. The demand for stronger, more secure EV certificates comes in the wake of increased phishing websites using Domain Validated (DV) certificates. Phishing websites imitate legitimate websites to steal customers' funds and identities. Phishi
CBT Pharmaceuticals to Grow Immuno-Oncology Pipeline by License Agreement of CrownBio CTLA-4 Antibody22.3.2018 14:43 | Pressemelding
SAN DIEGO, March 22, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announced today a strategic licensing agreement with CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies. The agreement gives CBT exclusive world-wide development and commercialization rights to a novel, recombinant, human monoclonal antibody which targets a differentiated epitope on the cytotoxic T-lymphocyte antigen-4 (CTLA-4) molecule. Binding of this antibody to CTLA-4 blocks the interaction of CTLA-4 with its ligands CD80/CD86 thus allowing the cytotoxic T cells to function actively. Under the terms of this global licensing agreement, CBT gain
Cloudflare Announces Mobile SDK to Monitor Network Performance for Applications22.3.2018 14:00 | Pressemelding
New free solution delivers network analytics to any mobile app developer SAN FRANCISCO, March 22, 2018 (GLOBE NEWSWIRE) -- Cloudflare, the leading Internet performance and security company, today announced the Cloudflare Mobile SDK, a free solution that enables any mobile app developer to understand network performance and metrics. Consumers are frustrated by mobile apps that are slow, crash, or deliver errors that degrade the user experience. For mobile app developers, a bad user experience means poor reviews, lower engagement, and reduced conversion on business metrics. Delivering consistent app performance requires focusing on every link in the chain: app code, network calls between the app and edge networks, and server infrastructure. There are a number of solutions that give developers analytics on their applications, but there has never been a way for app developers to understand how often their apps fail due to network errors. App developers easily integrate the Cloudflare Mobil
Compuware: Survey Shows Critical Mainframe Workloads Increasing While Mainframe Staff Losses Remain Unfilled22.3.2018 13:00 | Pressemelding
Many Organizations Not Measuring, Prioritizing Vital Key Performance Indicators 57 percent of enterprises with a mainframe currently run more than half of their business-critical applications on the platform-with that number expected to increase to 64 percent by next year. 72 percent of customer-facing applications are completely or very dependent on mainframe processing. Enterprises have only replaced 37 percent of the mainframe workforce lost over the past five years. Many organizations surveyed are not currently measuring velocity or efficiency key performance indicators, putting them at a disadvantage in the digital age. DETROIT, March 22, 2018 (GLOBE NEWSWIRE) -- The mainframe is becoming more important to large enterprises, with the percentage of organizations running at least half their business-critical applications on that platform expected to increase next year. However, the loss of skilled mainframe staff, and the failure to subsequently fill these positions, pose significan
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom