Breaking News
February 20, 2019 - Researchers unlock plant’s secret of producing specialized metabolites
February 20, 2019 - Newly released national framework identifies obstacles to improving EMS systems
February 20, 2019 - Exercise can shift human body clock depending on time when people work out
February 20, 2019 - Female adolescent blood donors more likely to have iron deficiency and related anemia
February 20, 2019 - Rubicon level linked to inhibition of autophagic process
February 20, 2019 - Researchers find potential therapeutic strategy to treat Alzheimer’s
February 20, 2019 - New forms of older anti-cancer agent appear to enhance immune response to fight melanoma
February 20, 2019 - Health Tip: Eat Less Saturated Fat
February 20, 2019 - Sleeping in contact lenses puts you at risk of dangerous infection
February 20, 2019 - “We should study that!”: How a nurse-scientist found her passion
February 20, 2019 - Cervical microbiome may influence HPV infection more than previously thought
February 20, 2019 - Sausage mislabeling in Canada is down, new study finds
February 20, 2019 - Study shows blood pressure benefits of morning exercise for older overweight/obese adults
February 20, 2019 - New screening method could catch organ rejection much earlier without a biopsy needle
February 20, 2019 - Study may have important implications for refining parenting during child’s adolescence
February 20, 2019 - Study sheds new light on how antibiotic resistance genes are transferred between bacteria
February 20, 2019 - Chronic Wasting Disease may soon spread to humans, warns CDC
February 20, 2019 - Scientists identify new genetic causes linked to abnormal pregnancies and miscarriages
February 20, 2019 - Using LyoSpeed technology to avoid residual solvent when drying HPLC fractions
February 20, 2019 - New screening tool more likely to identify sexual and labor exploitation of youth
February 20, 2019 - Newly licensed nurses work for long hours, also have a second paid job
February 20, 2019 - Physicists identify simple mechanism used by deadly bacteria to fend off antibiotics
February 20, 2019 - FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib
February 20, 2019 - Exposure to chemicals before and after birth is associated with a decrease in lung function
February 20, 2019 - Neuroscientists reveal that simple brain region can guide complex feats of mental activity
February 20, 2019 - Study finds new link between food allergies and multiple sclerosis
February 20, 2019 - First gene therapy operation for macular degeneration is a success
February 20, 2019 - Physicians graduated outside the U.S. offer better care for Medicare patients with complex needs
February 20, 2019 - Study shows therapeutic potential of VEGF-A mRNA for regenerative angiogenesis in humans
February 20, 2019 - FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection
February 20, 2019 - Study identifies brain cells that modulate behavioral response to threats
February 20, 2019 - Researchers take closer look at how viruses bind cells and cause infection
February 20, 2019 - Newly developed gene therapy helps decelerate aging process
February 20, 2019 - Study suggests new treatment strategy for deadly brain cancer
February 20, 2019 - Scientists develop unique hybrid implant that imitates bone structure
February 20, 2019 - Push-ups can be tailored to meet specific needs of individuals
February 20, 2019 - Early-career job loss has long term health implications
February 20, 2019 - CVD Does Not Modify Depression-Mortality Link in Elderly
February 20, 2019 - Electrical activity early in fruit flies’ brain development could shed light on how neurons wire the brain
February 20, 2019 - Machine learning technique helps predict which asthma patients respond to corticosteroid therapy
February 20, 2019 - Self-reported sleep duration is a useful tool to measure sleep in children, study suggests
February 20, 2019 - T-cells play key role in how the body fights follicular lymphoma
February 20, 2019 - Study shows how 3D organization of genetic material helps perpetuate the species
February 20, 2019 - Researchers engineer stem cell with ‘suicide genes’ to induce cell death in all but beta cells
February 20, 2019 - Study reveals major sex differences in management of cardiovascular risk factors among U.S. adults
February 20, 2019 - Health Tip: Get Your Child to School on Time
February 20, 2019 - Shortcut strategy for screening compounds with clinical potentials for drug development
February 20, 2019 - Common acid reflux drugs tied to elevated risk for kidney disease
February 20, 2019 - Microbiome could be culprit when good drugs do harm
February 20, 2019 - Prenatal exposure to forest fires causes stunted growth in children
February 20, 2019 - Gene therapy restores hearing in mice with congenital genetic deafness
February 20, 2019 - First molecular test predicts treatment response for kidney cancer
February 20, 2019 - New method for improved visualization of single-cell RNA- sequencing data
February 20, 2019 - Researchers capture altered brain activity patterns of Parkinson’s in mice
February 20, 2019 - A possible blood test for detecting Alzheimer’s disease before symptoms show
February 20, 2019 - Primary care physicians associated with longevity, new research finds
February 19, 2019 - New study identifies many key lessons to establish sanctioned safe consumption sites
February 19, 2019 - Single CRISPR treatment can safely and stably correct genetic disease
February 19, 2019 - Multinational initiative to study familial primary distal renal tubular acidosis
February 19, 2019 - Breakthrough study highlights the promise of cell therapies for muscular dystrophy
February 19, 2019 - Subsymptom Threshold Exercise Speeds Concussion Recovery
February 19, 2019 - Midline venous catheters – infants: MedlinePlus Medical Encyclopedia
February 19, 2019 - Searching for side effects
February 19, 2019 - Humanity is all right, probably, although human extinction remains quite possible, researcher says
February 19, 2019 - Having Anesthesia Once as a Baby Does Not Cause Learning Disabilities, New Research Shows
February 19, 2019 - Anti-cancer immunotherapy could be used to fight HIV
February 19, 2019 - Customized Micropatterning for Improved Physiological Relevance
February 19, 2019 - Unique gene therapy approach paves new way to tackle rare, inherited diseases
February 19, 2019 - Activating gene that helps excite neurons reverses depression in male mice
February 19, 2019 - Science Puzzling Out Differences in Gut Bacteria Around the World
February 19, 2019 - Cells that destroy the intestine
February 19, 2019 - On recovery, vulnerability and ritual: An exhibit in white
February 19, 2019 - Scientific Duo Gets Back To Basics To Make Childbirth Safer
February 19, 2019 - COPD patients need more support when understanding new chest symptoms
February 19, 2019 - Using light-based method for production of pharmaceutical molecules
February 19, 2019 - Scientists find link between inflammation and cancer
February 19, 2019 - The High Cost Of Sex: Insurers Often Don’t Pay For Drugs To Treat Problems
February 19, 2019 - Hearing impairment associated with accelerated cognitive decline with age
February 19, 2019 - Researchers identify multiple genetic variants associated with body fat distribution
February 19, 2019 - Influenza and common cold are completely different diseases, study shows
RedHill Announces Positive Top-Line Results from Confirmatory Phase 3 Study with Talicia for H. pylori Infection

RedHill Announces Positive Top-Line Results from Confirmatory Phase 3 Study with Talicia for H. pylori Infection

image_pdfDownload PDFimage_print

TEL-AVIV, Israel and RALEIGH, N.C., USA, December 3, 2018 — RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal (GI) diseases, announced today positive top-line results from the ERADICATE Hp2 study, a two-arm, randomized, double-blind, active comparator-controlled, confirmatory Phase 3 study with Talicia (RHB-105)1 for H. pylori infection.

The ERADICATE Hp2 study successfully met its primary endpoint with a high degree of statistical significance, demonstrating 84% eradication of H. pylori infection with Talicia versus 58% in the active comparator arm in the intent-to-treat (ITT) population (p<0.0001). No safety issues were reported in the study and Talicia was found to be well tolerated.

Dror Ben-Asher, RedHill’s CEO, stated: “We are delighted with these excellent top-line results and are preparing for U.S. New Drug Application (NDA) submission, expected in the first half of 2019, subject to FDA feedback. Our established U.S. commercial operations team and GI-focused sales force are well-positioned for the potential U.S. commercial launch of Talicia, expected in the second half of 2019, subject to FDA approval.”

Talicia is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole. The ERADICATE Hp2 two-arm, randomized, double-blind, active comparator-controlled study investigated 455 dyspepsia patients with confirmed H. pylori infection at 55 clinical sites across the U.S. Subjects were randomized 1:1 to receive four capsules, three times daily, of either Talicia or the active comparator, a dual therapy amoxicillin and omeprazole regimen at equivalent doses, for a period of 14 days.

The efficacy of current standard-of-care therapies continues to decline and has been reported in literature to be approximately 60%2 due to high resistance of H. pylori bacteria to the antibiotics commonly used in these therapies, primarily clarithromycin and metronidazole.

Preliminary H. pylori culture results taken throughout the ERADICATE Hp2 study from patients across 20 U.S. states confirmed the high resistance3 of H. pylori to the antibiotics most commonly used for treatment, clarithromycin (17% resistance) and metronidazole (43% resistance). Importantly, no resistance to rifabutin, a key component in Talicia’s unique and proprietary formulation, was detected in the study.

Moreover, consistent with the literature describing the diminished efficacy of standard-of-care therapies, preliminary results4 from the open-label part of the ERADICATE Hp2 Phase 3 study showed 64% eradication of H. pylori with these therapies.

Results from the ERADICATE Hp2 study showed consistent 21-29% treatment benefit of Talicia versus the active comparator across all H. pylori culture susceptibility and resistance subgroups, including amoxicillin, clarithromycin and metronidazole.

“The growing resistance of H. pylori to the antibiotics commonly used in standard-of-care therapies was confirmed in this study, which demonstrated the high resistance of the Helicobacter bacteria to clarithromycin and metronidazole. The resulting high failure rates of standard-of-care treatments, estimated at 30-40%, are a major public concern among the medical community worldwide and underscore the urgent need for new H. pylori eradication therapies, especially those utilizing antibiotics where resistance is rare such as amoxicillin   and rifabutin,” stated Professor David Graham, M.D., M.A.C.G., lead investigator of the ERADICATE Hp2 study.

The ERADICATE Hp2 Phase 3 top-line results confirm the positive findings demonstrated in RedHill’s previously reported first Phase 3 study (ERADICATE Hp) and further support Talicia’s potential to become a next generation, best-in-class, first-line therapy for treating H. pylori infection. RedHill plans to share ERADICATE Hp2 data in greater detail at upcoming scientific conferences.

Talicia was granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track development designation by the FDA, including eligibility for six-month priority review and a total of eight years of U.S. market exclusivity. Talicia is also covered by U.S. patents which extend patent protection until at least 2034, with additional pending patents and applications in various territories worldwide.

H. pylori bacterial infection affects over 50% of the adult population worldwide5 and 30-40% of the U.S. population6, with an estimated 2.5 million patients treated annually in the U.S.7

H. pylori infection is the strongest risk factor for the development of gastric cancer8 and a major risk factor for development of peptic ulcer disease9.

Ira Kalfus, M.D. RedHill’s medical director, added: “I am thrilled with the study results which support the outstanding efficacy of Talicia for treating H. pylori infection. The excellent results from both Phase 3 studies could position Talicia to become the new standard-of-care, best-in-class, first-line therapy for eradication of H. pylori. I look forward to further discussion with FDA about advancing this potential new therapy for H. pylori infection towards an NDA submission. I would like to thank all the patients, physicians and clinical staff who were involved in this study, as well as the lead investigator of the study, Professor David Graham and the RedHill team for their commitment to benefiting people infected with H. pylori.”

RedHill will continue to analyze the top-line data from the ERADICATE Hp2 study, including antibiotic susceptibility and resistance, and plans to meet with the FDA to present the data and discuss the path towards potential marketing approval of Talicia in the U.S.

The ERADICATE Hp2 study top-line results were provided to RedHill by an independent third-party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the Clinical Study Report.

About Talicia (RHB-105)

Talicia (RHB-105) is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin and a proton pump inhibitor (PPI), omeprazole. Talicia is pursuing an indication of treatment of H. pylori infection, regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori infection. Talicia has been investigated in two positive Phase 3 studies for the treatment of H. pylori: The ERADICATE Hp2 confirmatory Phase 3 study met its primary endpoint, with top-line results demonstrating 84% eradication of H. pylori infection (p<0.0001). The ERADICATE Hp first Phase 3 study met its primary endpoint, demonstrating 89.4% efficacy in eradicating H. pylori infection with Talicia (p<0.001). Talicia was granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track development designation by the FDA, including eligibility for six-month priority review and a total of eight years of U.S. market exclusivity. Talicia is also covered by U.S. patents which extend patent protection until at least 2034, with additional pending patents and applications in various territories worldwide.

About the ERADICATE Hp2 study

The ERADICATE Hp2 confirmatory Phase 3 study is a two-arm, randomized, double-blind, active comparator-controlled, confirmatory Phase 3 study which compared Talicia against a dual therapy amoxicillin and omeprazole regimen at equivalent doses. The study investigated 455 dyspepsia patients with confirmed H. pylori infection at 55 clinical sites across the U.S. Subjects were randomized 1:1 to receive four capsules, three times daily, of either Talicia or the active comparator, for a period of 14 days. Subjects were assessed for the study’s primary endpoint of eradication of H. pylori infection at least 43 days after initiation of treatment. The study was 90% powered to detect a 13% treatment effect (active arm 83% vs. control arm 70%). Patients in the study who remained H. pylori-positive after completing treatment in either arm were offered treatment with standard-of-care therapies that included clarithromycin and/or metronidazole-based triple therapy or quadruple therapy, in an open-label setting.

About H. pylori         

H. pylori bacterial infection affects over 50% of the adult population worldwide8 and 30-40% of the U.S. population6, with an estimated 2.5 million patients treated annually in the U.S.

H. pylori is classified as a group I carcinogen by the International Agency for Research on Cancer. It is the strongest risk factor for the development of gastric cancer8 and a major risk factor for peptic ulcer disease9, and gastric mucosa-associated lymphoid tissues (MALT) lymphoma10. Eradication of H. pylori is becoming more difficult; Current standard-of-care therapies fail in approximately 30-40% of patients, who remain H. pylori positive, due to increasing resistance of H. pylori to antibiotics commonly used in standard combination therapies3. Clarithromycin-resistant H. pylori was formally categorized by the World Health Organization as a pathogen for which there is a high priority need to develop new treatments11. The 2018 global market for H. pylori eradication therapies is estimated at approximately $4.8 billion, of which $1.4 billion is from the U.S.

The ERADICATE Hp2 confirmatory Phase 3 study with Talicia (RHB-105) is registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health (NIH), which provides access to information on publicly and privately supported clinical studies.

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 promote Donnatal®, Mytesi® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg and commercialize 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 22, 2018. 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.

  1. 1 Talicia® (RHB-105) is an investigational new drug, not available for commercial distribution.
  2. 2 Fallone CA et al. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology 2016;151:51–69.
  3. 3 Savoldi A et al. Prevalence of antibiotic resistance in Helicobacter pylori: a systematic review and meta-analysis in World Health Organization regions. Gastroenterology 2018;155:1372-1382; Malfertheiner, P., et al. Management of Helicobacter pylori infection—the Maastricht V/Florence consensus report. Gut 2017;66.1:6-30.
  4. 4 N=82; Not all patients in the open-label part have completed last visit; therapy in open-label part was determined by the treating physician.
  5. 5 Kakelar HM et al. Pathogenicity of Helicobacter pylori in cancer development and impacts of vaccination. Gastric Cancer 2018:1-14.
  6. 6 Chey WD et al. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol 2007;102:1808–1825.
  7. 7 Foster Rosenblatt market analysis, October 2018.
  8. 8 Lamb A et al. Role of the Helicobacter pylori‐Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
  9. 9 NIH – Helicobacter pylori and Cancer, September 2013.
  10. 10 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
  11. 11 http://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed.

Source: RedHill Biopharma Ltd.

Posted: December 2018

Tagged with:

About author

Related Articles