Talicia® - World Gastro 2022 congress
(August 17-18): RedHill
invited to give prestigious oral presentation of important data
detailing high eradication rates across body mass index
(BMI) groups with Talicia, the U.S.'s leading brand for
Helicobacter pylori (H. pylori) eradication treatment -
invitation sent to researchers with significant recently published
clinical findings
--
Opaganib for COVID-19 – Suggested host-directed
mechanism of action described in Drug Design, Development and
Therapy journal: Multi-faceted potential to: Inhibit
spike protein-ACE2 binding, Akt signaling and endocytosis, induce
autophagy and apoptosis, and disrupt the viral
replication-transcription complex (RTC) through simultaneous
inhibition of three sphingolipid-metabolizing enzymes in human
cells (SK2, DES1 and GCS) - supports hypothesis of broad antiviral
effect and attenuation of multi-organ dysfunction in COVID-19
patients
--
Opaganib for COVID-19 - 2nd ARDS Drug Development Summit
(July 13-15): Presenting
new COVID-19 biomarker methodology utilizing baseline Fraction
of Inspired Oxygen (FiO2) as a new disease severity
classification paradigm - Phase 2/3 data demonstrating a 62%
reduction in mortality in opaganib-treated patients requiring
FiO2 up to 60% to be presented
--
Opaganib and RHB-107 (upamostat) for COVID-19 -
International Conference on Emerging Infectious Diseases (ICEID,
August 7-10): Presenting
promising efficacy and safety data for RedHill's novel, oral,
variant-agnostic investigational COVID-19 therapies, at ICEID, the
premier infectious disease conference hosted by the CDC and the
Global Task Force for Health
RALEIGH,
N.C. and TEL AVIV,
Israel, July 12, 2022 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, announced the upcoming
presentation of new Talicia® H. pylori
eradication data as well as publication and presentation of data
from the opaganib and RHB-107 (upamostat) late clinical-stage
COVID-19 programs at important medical congresses in July and
August, 2022.
Talicia[1]: Publication of a study
entitled "Helicobacter pylori Eradication by Low-Dose
Rifabutin Triple Therapy (Talicia®) is Unaffected by
High Body Mass Index" in the journal GastroHep has been selected by
reviewers for oral presentation at the World Gastro 2022 congress,
August 17-18. Such invitations to
present are reserved for researchers with significant clinical
findings published over the previous year. This post hoc
analysis of 269 patients from the ERADICATE Hp and ERADICATE Hp2
Phase 3 clinical trials, demonstrated that Talicia is highly
effective in eradicating H. pylori irrespective of patient
BMI, including in obese and severely obese patients, compared to
the active comparator (P<0.0001). Patients with a BMI between
30-40 kg/m2 and those with BMI >40kg/m2
treated with Talicia achieved eradication rates of approximately
90% (88.1% and 90.9% respectively) versus active comparator rates
of 62.9% and 31.8% respectively - an approximately 50% lower
eradication rate in the severely obese group for the active
comparator. Talicia is the leading U.S. branded prescription
medicine for H. pylori eradication.
Dr. June Almenoff, MD, Ph.D.,
RedHill's Chief Medical Officer, said: "Because more than 70%
of Americans are either overweight or obese[2], and
because increased BMI has been linked to reduced eradication
outcomes of many commonly used H. pylori therapies, this
important work supports Talicia as a rational first line option
regardless of patient BMI."
RedHill's novel, oral, variant-agnostic late clinical-stage
COVID-19 drug candidates, opaganib and RHB-107, have had data
selected for publication or presentation as follows:
Opaganib[3]: Suggested host-directed
mechanism of action described in a manuscript entitled "Recent
Progress in the Development of Opaganib for the Treatment of
COVID-19" accepted for publication in the journal Drug Design,
Development and Therapy: The paper outlines opaganib's
multi-faceted potential to: inhibit spike protein-ACE2 binding, Akt
signaling and endocytosis, induce autophagy and apoptosis, and
disrupt the viral RTC (replication-transcription complex) through
simultaneous inhibition of three sphingolipid-metabolizing enzymes
in human cells (SK2, DES1 and GCS). These mechanisms support the
hypothesis of broad antiviral effect and attenuation of multi-organ
dysfunction in COVID-19 patients. Moreover, because of this
tripartite targeting, viral resistance to opaganib is unlikely to
be encountered through adaptive mutation during therapy or random
mutation to generate additional viral variants.
2nd ARDS Drug Development Summit, Boston, July
13-15: Data to be presented from the opaganib Phase 2/3
study showing the potential for a new methodology for selecting
COVID-19 patients for treatment with opaganib, based on a new
paradigm for classification of disease severity utilizing baseline
Fraction of Inspired Oxygen (FiO2), in which opaganib demonstrated
a 62% reduction in mortality in patients requiring FiO2 up to
60%.
Opaganib and RHB-107 (upamostat)[4]:
International Conference on Emerging Infectious Diseases (ICEID),
Atlanta, August 7-10: Data to be presented at ICEID,
the premier infectious disease conference hosted by the CDC and the
Global Task Force for Health, will include: Prespecified analyses
from opaganib's Phase 2/3 study (NCT04467840), showing improved
viral RNA clearance, faster time to recovery and reduced mortality
in key subpopulations of opaganib treated moderate to severe
hospitalized patients with COVID-19. Data for RHB-107, from Part A
of its two-part Phase 2/3 study in a non-hospitalized setting,
includes demonstration of a 100% reduction in hospitalization due
to COVID-19 and an approximately 88% reduction in reported new
severe COVID-19 symptoms after treatment initiation.
Dr. Mark Levitt, RedHill's Chief Scientific Officer
said: "Acceptance for publication and presentation of these
important data is testament to the quality and strength of
RedHill's R&D capability. Oral opaganib and oral RHB-107, both
of which have novel host-targeting antiviral mechanisms, have shown
effect across multiple variants and virus models, and could serve
as important tools in responding to the current and future pandemic
waves, whether caused by SARS-COV-2 variants or by other viruses,
and of particular concern, as Fall/Winter approach, is the specter
of both COVID-19 and influenza circulating in abundance. We are
seeing a shift in focus of government funding sources, public
health experts, institutions and industry towards looking for broad
host-directed antiviral mechanisms of action that will not be
subject to resistance by viral mutation and that could address
emerging new variants of SARS-CoV-2 and also combat other viruses
that might create future pandemic waves - a more sustainable
long-term approach than having to rediscover and reinvent very
specific antiviral therapeutics which quickly become obsolete in
the face of rapidly mutating viruses."
About H. pylori infection
H.
pylori is a bacterial infection that affects approximately
35%[5] of the U.S. population, with an estimated two
million patients treated annually[6]. 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 cancer[7] and a major risk factor for
peptic ulcer disease[8] and gastric
mucosa-associated lymphoid tissue (MALT) lymphoma[9].
More than 27,000 Americans are diagnosed with gastric cancer
annually[10]. 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 – especially
clarithromycin – which is still commonly used in standard
combination therapies[11].
About Talicia
Talicia is the only low-dose
rifabutin-based therapy approved for the treatment of H.
pylori infection and is designed to address H. pylori's
high resistance to other antibiotics. The high rates of H.
pylori resistance to clarithromycin have led to
significant rates of treatment failure with clarithromycin-based
therapies and are a strong public health concern, as highlighted by
the ACG, 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 adherent[12] to their
therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in
the active comparator arm[13].
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 Opaganib (ABC294640)
Opaganib, a new chemical
entity, is a proprietary, first-in-class, orally-administered,
investigational sphingosine kinase-2 (SK2) selective inhibitor,
with suggested dual anti-inflammatory and antiviral activity.
Opaganib is host-targeted and, based on data accumulated to date,
is expected to maintain effect against emerging viral variants,
having already shown in vitro inhibition against variants of
concern, including Omicron and Delta. Opaganib
has also shown anticancer activity and positive preclinical results
in renal fibrosis, and has the potential to target multiple
oncology, viral, inflammatory, and gastrointestinal
indications.
In prespecified analyses of Phase 2/3 clinical data, oral
opaganib has demonstrated improved viral RNA clearance, faster time
to recovery and significant mortality reduction in key patient
subpopulations versus placebo on top of standard of care. Data from
the opaganib global Phase 2/3 study has been submitted for peer
review and recently published in medRxiv. Opaganib previously
delivered promising U.S. Phase 2 data in patients with moderate to
severe COVID-19, published in Open Forum Infectious Diseases.
Opaganib has also received Orphan Drug designation from the
U.S. FDA for the treatment of cholangiocarcinoma and is being
evaluated in a Phase 2a study in advanced cholangiocarcinoma and in
a Phase 2 study in prostate cancer. Patient accrual, treatment and
analysis in the prostate cancer study are ongoing.
Opaganib demonstrated potent antiviral activity against
SARS-CoV-2, the virus that causes COVID-19, inhibiting viral
replication of the original SARS-CoV-2 and variants tested to date
in an in vitro model of human lung bronchial
tissue. Additionally, preclinical in vivo studies
have demonstrated opaganib's potential to decrease renal fibrosis,
have shown decreased fatality rates from influenza virus infection,
and amelioration of bacteria-induced pneumonia lung injury with
reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage
fluids[14].
The ongoing clinical studies with opaganib are registered
on www.ClinicalTrials.gov, a web-based service by the U.S.
National Institute of Health, which provides public access to
information on publicly and privately supported clinical
studies.
About RHB-107 (upamostat)
RHB-107 is a proprietary,
first-in-class, once-daily orally-administered investigational
antiviral, that targets human serine proteases involved in
preparing the spike protein for viral entry into target cells.
Because it is host-cell targeted, RHB-107 is expected to also be
effective against emerging viral variants with mutations in the
spike protein. RHB-107 is being evaluated in a Phase 2/3 study for
treatment of patients with symptomatic COVID-19 who do not require
inpatient care. In addition, RHB-107 inhibits several proteases
targeting cancer and inflammatory gastrointestinal disease. RHB-107
has undergone several Phase 1 studies and two Phase 2 studies,
demonstrating its clinical safety profile in approximately 200
patients. RedHill acquired the exclusive worldwide rights to
RHB-107, excluding China,
Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE:
HPHA) (formerly WILEX AG) for all indications.
About RedHill Biopharma
RedHill 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[15], Talicia® for
the treatment of Helicobacter pylori (H. pylori) infection
in adults, and Aemcolo® for the treatment of
travelers' diarrhea in adults[16]. RedHill's
key clinical late-stage development programs include: (i)
RHB-204, with an ongoing Phase 3 study for pulmonary
nontuberculous mycobacteria (NTM) disease; (ii) opaganib
(ABC294640), a first-in-class oral SK2 selective
inhibitor targeting multiple indications with a Phase 2/3 program
for hospitalized COVID-19 and Phase 2 studies for prostate cancer
and cholangiocarcinoma ongoing; (iii) RHB-107
(upamostat), an oral serine protease inhibitor in a Phase
3-stage study as treatment for non-hospitalized symptomatic
COVID-19, and targeting multiple other cancer and inflammatory
gastrointestinal diseases; (iv) RHB-104, with positive
results from a first Phase 3 study for Crohn's disease; (v)
RHB-102 , with positive results from a Phase 3 study for
acute gastroenteritis and gastritis and positive results from a
Phase 2 study for IBS-D; and (vi) RHB-106, an
encapsulated bowel preparation. More information about the Company
is available at www.redhillbio.com/ twitter.com/RedHillBio.
TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION
Talicia 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.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson
syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been
reported with rifabutin, amoxicillin, and omeprazole. Additionally,
drug reaction with eosinophilia and systemic symptoms (DRESS) has
been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients
taking PPIs and penicillins.
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.
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, including
without limitation risks regarding the treatment effectiveness of
Talicia® and the risk that the Company will not
succeed to expand Talicia's reach to additional ex-U.S.
territories; as well as other risk 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; (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
Talicia®; (v) the Company's ability to successfully
commercialize and promote Talicia®, 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 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 March 17, 2022. 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
Chief Corporate &
Business Development Officer
RedHill
Biopharma
+972-54-6543-112
adi@redhillbio.com
|
Media
contacts:
U.S. / UK: Amber
Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
Category: R&D
[1] Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) is approved in the U.S. and indicated
for the treatment of H. pylori infection in adults. For full
prescribing information see: www.Talicia.com
[2] Adult Obesity Facts. Atlanta, GA: Centers for Disease Control and
Prevention (CDC); 2020.
https://www.cdc.gov/obesity/data/adult.html.
[3] Opaganib is an investigational new drug, not
available for commercial distribution.
[4] RHB-107 is an investigational new drug, not
available for commercial distribution.
[5] Hooi JKY et al. Global Prevalence of
Helicobacter pylori Infection: Systematic Review and
Meta-Analysis. Gastroenterology 2017; 153:420-429.
[6] IQVIA Custom Study for RedHill Biopharma,
2019
[7] 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.
[8] NIH – Helicobacter pylori and Cancer,
September 2013.
[9] 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.
[10] National Cancer Institute, Surveillance,
Epidemiology, and End Results Program (SEER).
[11] 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.
[12] 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.
[13] 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).
[14] Xia C. et al. Transient inhibition of
sphingosine kinases confers protection to influenza A virus
infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et
al. Pseudomonas aeruginosa stimulates nuclear
sphingosine-1-phosphate generation and epigenetic regulation of
lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
[15] Movantik® (naloxegol) is indicated for
opioid-induced constipation (OIC). Full prescribing information
see: www.movantik.com.
[16] Aemcolo® (rifamycin) is indicated for
the treatment of travelers' diarrhea caused by noninvasive strains
of Escherichia coli in adults. For full prescribing
information see: www.aemcolo.com.
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