RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”),
a specialty biopharmaceutical company, today announced that new
data supporting the use of Talicia®1 as a first-line therapy for
eradication of H. pylori in adults was presented at the American
College of Gastroenterology (ACG) 2020 Virtual Annual Scientific
Meeting. The Company also presented data highlighting the emerging
patterns of H. pylori resistance to antibiotics used in current
standard-of-care therapies.
A key objective of the new U.S. Government
"National Action Plan for Combating Antibiotic-Resistant Bacteria,
2020-2025"2 is lowering the annual rate of inappropriate outpatient
antibiotic prescribing. Efficacy of treatments for H. pylori, one
of the most prevalent infections in the U.S. and the leading cause
of gastric cancer, has been steadily declining due to increasing
levels of antibiotic resistance3. In tackling this problem, it is
important to ensure successful first-line eradication of H. pylori
infection. The analyses presented by RedHill at the ACG annual
meeting aim to provide insights that may help avoid the risk of
antibiotic resistance in the eradication of H. pylori.
Poster 1:
Persistent H. pylori
infection following participation in two randomized
controlled trials: Outcomes of
patients receiving physician-directed standard-of-care
therapy4. This analysis of data from the Talicia Phase 3
studies looked at the cure rates of physician-directed
standard-of-care therapy for persistent H. pylori infection. The
analysis found that eradication rates with empiric
clarithromycin-based triple therapy were predictably low, and that
despite declining efficacy of clarithromycin-containing therapies,
physicians are still prescribing these regimens.
“Despite the ACG treatment guideline
recommendations for avoiding clarithromycin-containing triple
therapy in patients with prior macrolide use and as salvage
treatment, as well as other recommended restrictions based on
resistance, clarithromycin-based therapies unfortunately remain an
all too often prescribed treatment for H. pylori,”
said Dr. Colin W. Howden,
MD, AGAF, FACG, Hyman Professor of Medicine & Chief of the
Division of Gastroenterology, University of Tennessee Health
Science Center. “Because H. pylori
treatment is largely empiric, it is important that physicians
prescribe a first-line regimen with the highest probability of
successful eradication. A treatment regimen that does not contain
clarithromycin, such as low dose rifabutin-based therapy, is a good
first-line option to consider for H. pylori eradication.”
Poster 2:
Efficacy of H.
pylori eradication by
low-dose rifabutin triple therapy
(RHB-105) is
unaffected by BMI: Post-hoc analysis from two
Phase 3 trials5.Winner of the ACG
“Outstanding Poster Presenter” Award.With rising rates of obesity
in the U.S., and published data suggesting that Body Mass Index
(BMI) may be associated with the failure of clarithromycin-based H.
pylori treatments6, it is imperative to study the influence of
patient BMI on treatment success. This post-hoc analysis assessed
the impact of BMI on eradication rates of H. pylori in patients
with a BMI of both above and below 40, with results demonstrating
that eradication rates with Talicia remained within the same high
range, irrespective of patient BMI status. This maintenance of
Talicia efficacy compares to an almost 50% reduction of eradication
rates in amoxicillin/omeprazole-comparator-treated patients with
BMI ≥40.
“Antibiotic treatment failure in obese
populations with H. pylori is a significant concern and may be
linked to elevations in BMI,” said Dr. June Almenoff,
MD, Ph.D., RedHill’s Chief Scientific Officer. “Given the
trends of increasing BMI and growing antibiotic resistance in the
U.S., it is critical to work towards first-line H.
pylori eradication success in all patients irrespective of
BMI. These data demonstrate that Talicia’s efficacy rates were
similarly high across patient sub-groups by BMI.”
About Talicia
(omeprazole magnesium, amoxicillin and
rifabutin)Talicia is the only rifabutin-based therapy
approved for the treatment of H. pylori infection and is designed
to address the high resistance of H. pylori bacteria to commonly
used clarithromycin-based therapies. The high rates of H. pylori
resistance to clarithromycin have led to significant rates of
treatment failure with clarithromycin-based therapy and are a
strong public health concern, as highlighted by the FDA and the
World Health Organization (WHO) in recent years. Talicia is a
novel, fixed-dose, all-in-one oral capsule combination of two
antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor
(PPI) (omeprazole). In November 2019, Talicia was approved by the
U.S. FDA for the treatment of H. pylori infection in adults. In the
pivotal Phase 3 study, Talicia demonstrated 84% eradication of H.
pylori infection in the intent-to-treat (ITT) group vs. 58% in the
active comparator arm (p<0.0001). Minimal to zero resistance to
rifabutin, a key component of Talicia, was detected in RedHill’s
pivotal Phase 3 study. Further, in an analysis of data from this
study, it was observed that subjects who were confirmed adherent7
to their therapy had eradication rates of 90.3% in the Talicia arm
vs. 64.7% in the active comparator arm8.Talicia is eligible for a
total of eight years of U.S. market exclusivity under its Qualified
Infectious Disease Product (QIDP) designation and is also covered
by U.S. patents which extend patent protection until 2034 with
additional patents and applications pending and granted in various
territories worldwide.About H.
pyloriH. pylori is a bacterial infection that affects
approximately 35%9 of the U.S. population, with an estimated two
million patients treated annually10. Worldwide, more than 50% of
the population has H. pylori infection, which is classified by the
WHO as a Group 1 carcinogen. It remains the strongest known risk
factor for gastric cancer11 and a major risk factor for peptic
ulcer disease12 and gastric mucosa-associated lymphoid tissue
(MALT) lymphoma13. More than 27,000 Americans are diagnosed with
gastric cancer annually14. Eradication of H. pylori is
becoming increasingly difficult, with current therapies failing in
approximately 25-40% of patients who remain H. pylori-positive
due to high resistance of H. pylori to antibiotics
commonly used in standard combination therapies15.
About RedHill BiopharmaRedHill
Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical
company primarily focused on gastrointestinal and infectious
diseases. RedHill promotes the gastrointestinal drugs,
Movantik® for opioid-induced
constipation in adults with non-cancer pain16,
Talicia® for the treatment of Helicobacter pylori
(H. pylori) infection in adults17, and
Aemcolo® for the treatment of
travelers’ diarrhea in adults18. RedHill’s key clinical late-stage
investigational development programs include: (i)
RHB-204, with a planned Phase 3 study for
pulmonary nontuberculous mycobacteria (NTM) infections; (ii)
opaganib
(Yeliva®), a
first-in-class SK2 selective
inhibitor targeting multiple indications with a Phase 2/3 program
for COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-104, with
positive results from a first Phase 3 study for Crohn's disease;
(iv) RHB-102
(Bekinda®), with positive results
from a Phase 3 study for acute gastroenteritis and gastritis and
positive results from a Phase 2 study for IBS-D; (v)
RHB-107, a Phase 2-stage first-in-class, serine
protease inhibitor, targeting cancer and inflammatory
gastrointestinal diseases and is also being evaluated for COVID-19
and (vi) RHB-106, an encapsulated
bowel preparation. More information about the Company is available
at www.redhillbio.com. TALICIA: INDICATION
AND USAGETalicia is a three-drug combination of
omeprazole, a proton pump inhibitor, amoxicillin, a
penicillin-class antibacterial, and rifabutin, a rifamycin
antibacterial, indicated for the treatment of Helicobacter
pylori infection in adults.
To reduce the development of drug-resistant
bacteria and maintain the effectiveness of Talicia and other
antibacterial drugs, Talicia should be used only to treat or
prevent infections that are proven or strongly suspected to be
caused by bacteria.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI),
amoxicillin, a penicillin-class antibacterial and rifabutin, a
rifamycin antibacterial. It is contraindicated in patients with
known hypersensitivity to any of these medications, any other
components of the formulation, any other beta-lactams or any other
rifamycin.
Talicia is contraindicated in patients receiving
rilpivirine-containing products.
Talicia is contraindicated in patients receiving
delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity
reactions have been reported with omeprazole, amoxicillin and
rifabutin.
Clostridioides difficile-associated diarrhea
(CDAD) has been reported with use of nearly all antibacterial
agents and may range from mild diarrhea to fatal
colitis. Talicia may cause fetal harm. Talicia is not
recommended for use in pregnancy.
Talicia may reduce the efficacy of hormonal
contraceptives. An additional non-hormonal method of contraception
is recommended when taking Talicia.
Talicia should not be used in patients with
hepatic impairment or severe renal impairment.
Acute Interstitial Nephritis has been observed
in patients taking PPIs and penicillins.
Cutaneous lupus erythematosus (CLE) and systemic
lupus erythematosus (SLE) have been reported in patients taking
PPIs. These events have occurred as both new onset and exacerbation
of existing autoimmune disease.
The most common adverse reactions (≥1%) were
diarrhea, headache, nausea, abdominal pain, chromaturia, rash,
dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal
candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact
RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is
available at www.Talicia.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 associated with (i) the initiation, timing, progress
and results of the Company’s research, manufacturing, pre-clinical
studies, clinical trials, and other therapeutic candidate
development efforts, and the timing of the commercial launch of its
commercial products and ones it may acquire or develop in the
future; (ii) the Company’s ability to advance its therapeutic
candidates into clinical trials or to successfully complete its
pre-clinical studies or clinical trials or the development of a
commercial companion diagnostic for the detection of MAP; (iii) the
extent and number and type 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 and commercial products; (v)
the Company’s ability to successfully commercialize and promote
Talicia®, and Aemcolo® and Movantik®; (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, pre-clinical 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 commercial products 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; (xiv) competition from other
companies and technologies within the Company’s industry; and (xv)
the hiring and maintaining employment of executive managers. 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 March 4, 2020. 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 FrishChief Corporate &
Business Development OfficerRedHill
Biopharma+972-54-6543-112adi@redhillbio.com |
Media contact (U.S.):Bryan
GibbVice PresidentFinn Partners+1 212 529
2236bryan.gibbs@finnpartners.com |
____________________
1 Omeprazole magnesium, amoxicillin and
rifabutin delayed release capsules. Also referred to as RHB-105 2
https://aspe.hhs.gov/pdf-report/carb-plan-2020-20253 Prevalence of
Antibiotic Resistance in Helicobacter pylori: A Systematic Review
and Meta-analysis in World HealthOrganization Regions. Alessia
Savoldi et al. Gastroenterology 2018;155:1372–1382.4 Persistent H.
pylori infection following participation in two randomized
controlled trials: Outcomes of patients receiving
physician-directed standard-of-care therapy. Colin W. Howden,
Raymond M. Panas, June S. Almenoff, and Willian D. Chey.5 Efficacy
of H. pylori eradication by low-dose rifabutin triple therapy
(rhb-105) is unaffected by BMI: Post-hoc analysis from two Phase 3
trials. Kely L. Sheldon, Steven F. Moss, Mohd Amer Alsamman, Elliot
Offman, Raymond M. Panas, and June S. Almenoff.6 Cerqueira, R. M.,
Correia, M. R., Fernandes, C. D., et al. (2013). Cumulative
Helicobacter pylori eradication therapy in obese patients
undergoing gastric bypass surgery. Obes Surg, 23(2), 145-149.
doi:10.1007/s11695-012-0747-4.7 Defined as the PK population which
included those subjects in the ITT population who had demonstrated
presence of any component of investigational drug at visit 3
(approx. day 13) or had undetected levels drawn >250 hours after
the last dose.8 The pivotal Phase 3 study with Talicia®
demonstrated 84% eradication of H. pylori infection with Talicia®
vs. 58% in the active comparator arm (ITT analysis, p<0.0001).9
Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection:
Systematic Review and Meta-Analysis. Gastroenterology 2017;
153:420-429.10 IQVIA Custom Study for RedHill Biopharma, 201911
Lamb A et al. Role of the Helicobacter pylori‐Induced inflammatory
response in the development of gastric cancer. J Cell Biochem
2013;114.3:491-497.12 NIH – Helicobacter pylori and Cancer,
September 2013.13 Hu Q et al. Gastric mucosa-associated lymphoid
tissue lymphoma and Helicobacter pylori infection: a review of
current diagnosis and management. Biomarker research 2016;4.1:15.14
National Cancer Institute, Surveillance, Epidemiology, and End
Results Program (SEER).15 Malfertheiner P. et al. Management
of Helicobacter pylori infection - the Maastricht IV/
Florence Consensus Report, Gut 2012;61:646-664; O’Connor A. et al.
Treatment of Helicobacter pylori Infection 2015,
Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of
bismuth quadruple therapy versus clarithromycin triple therapy for
empiric primary treatment of Helicobacter
pylori infection. Digestion 2013;88(1):33-45.16 Full
prescribing information for Movantik® (naloxegol) is available at:
www.Movantik.com.17 Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.18 Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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