TEL AVIV, Israel and
RALEIGH, N.C., May 24, 2021 /PRNewswire/ -- RedHill Biopharma
Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today announced presentation at
Digestive Disease Week (DDW) 2021 of two new analyses of
Movantik® Phase 3 study data demonstrating rapid onset
of action and sustained and predictable improvement of key symptoms
associated with opioid-induced constipation (OIC).
Both analyses included pooled data from two large, robust,
identically designed Phase 3 studies of Movantik (Kodiak 4 and
Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients
across two doses (12.5 mg and 25 mg), compared to a total of 546
patients in the placebo arms.
"These two new analyses demonstrate rapid and sustained efficacy
of naloxegol for a broad range of bothersome OIC symptoms,
positively impacting patient care. Given the challenge of OIC
symptoms, early symptom relief is an important therapeutic
consideration" said Prof. William D.
Chey, Director of the GI Physiology Laboratory at the
University of Michigan, and former
Co-Editor-in-Chief of the American Journal of
Gastroenterology.
Poster 1 (Poster Number: Sa059): Naloxegol
Achieved Rapid and Sustained Improvement of Opioid-Induced
Constipation (OIC) Symptoms: A Pooled Analysis of Two Global
Randomized Placebo-Controlled Trials[1]
Given the clinical importance of rapid and sustained OIC symptom
response, this analysis aims to evaluate the efficacy of naloxegol
(12.5 and 25 mg) on the key symptoms of OIC.
Poster 2 (Poster Number: Sa058): Rapid Onset of Time to First
Spontaneous Bowel Movement (SBM) and Predictable Efficacy of
Naloxegol: Pooled Analysis of Two Global Randomized Controlled
Trials[2]
Given the clinical importance of rapid and predictable symptom
response, this analysis aims to characterize the predictability of
the onset of response within 48 hours following the first dose of
naloxegol (12.5 mg and 25 mg).
"OIC is the most common and debilitating gastrointestinal
adverse effect associated with opioid therapy, estimated to affect
between 40-80% of the millions of patients taking chronic opioid
therapy each year[3]," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief
Scientific Officer. "Movantik has demonstrated its ability to
help overcome one of the main challenges of opioid-based chronic
pain management by bringing rapid and sustained relief from
OIC."
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[4], Talicia® for the
treatment of Helicobacter pylori (H. pylori) infection in
adults[5], and Aemcolo® for
the treatment of travelers' diarrhea in
adults[6]. 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 (Yeliva®,
ABC294640), a first-in-class SK2 selective
inhibitor targeting multiple indications with positive Phase 2
COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and
Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing;
(iii) RHB-107 (upamostat), a serine protease inhibitor in a
U.S. Phase 2/3 study as treatment for 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
(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; and (vi) RHB-106, an
encapsulated bowel preparation. More information about the Company
is available at www.redhillbio.com /
https://twitter.com/RedHillBio.
About Movantik® (naloxegol)
Movantik® is an opioid antagonist indicated for the treatment of
opioidinduced constipation (OIC) in adult patients with chronic
non-cancer pain, including patients with chronic pain related to
prior cancer or its treatment who do not require frequent (e.g.,
weekly) opioid dosage escalation.
Important Safety Information About Movantik
Movantik® (naloxegol) is contraindicated in:
- Patients with known or suspected gastrointestinal (GI)
obstruction and patients at risk of recurrent obstruction, due to
the potential for GI perforation.
- Patients receiving strong CYP3A4 inhibitors (e.g.,
clarithromycin, ketoconazole) because these medications can
significantly increase exposure to naloxegol which may precipitate
opioid withdrawal symptoms.
- Patients with a known serious or severe hypersensitivity
reaction to Movantik or any of its excipients.
Symptoms consistent with opioid withdrawal, including
hyperhidrosis, chills, diarrhea, abdominal pain, anxiety,
irritability, and yawning, occurred in patients treated with
Movantik. Patients receiving methadone as therapy for their pain
condition were observed in the clinical trials to have a higher
frequency of GI adverse reactions that may have been related to
opioid withdrawal than patients receiving other opioids. Patients
with disruptions to the blood-brain barrier may be at increased
risk for opioid withdrawal or reduced analgesia. These patients
(e.g., multiple sclerosis, recent brain injury, Alzheimer's
disease, and uncontrolled epilepsy) were not enrolled in the
clinical studies. Take into account the overall risk-benefit
profile when using Movantik in such patients. Monitor for symptoms
of opioid withdrawal when using Movantik in such patients.
Severe abdominal pain and/or diarrhea have been reported,
generally within a few days of initiation of Movantik. Monitor and
discontinue if severe symptoms occur. Consider restarting Movantik
at 12.5 mg once daily.
Cases of GI perforation have been reported with the use of
peripherally acting opioid antagonists, including Movantik.
Postmarketing cases of GI perforation, including fatal cases, were
reported when Movantik was used in patients at risk of GI
perforation (e.g., infiltrative gastrointestinal tract malignancy,
recent gastrointestinal tract surgery, diverticular disease
including diverticulitis, ischemic colitis, or concomitantly
treated with bevacizumab). Monitor for severe, persistent, or
worsening abdominal pain; discontinue if this symptom develops.
The most common adverse reactions with Movantik as compared to
placebo in clinical trials were: Abdominal pain (21% vs 7%),
diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%),
vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs
<1%).
Movantik (naloxegol) is indicated for the treatment of
opioid-induced constipation (OIC) in adult patients with chronic
non-cancer pain, including patients with chronic pain related to
prior cancer or its treatment who do not require frequent (e.g.,
weekly) opioid dosage escalation.
Click here for the Medication Guide and
full Prescribing Information for Movantik.
You are encouraged to report Adverse Reactions to RedHill
Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
MOVANTIK is a registered trademark of the AstraZeneca group of
companies.
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; the risk that the Company will not successfully
commercialize its products; as well as 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 Talicia®; (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 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
employment commencement date 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 18, 2021. 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 and
Business Development Officer
RedHill
Biopharma
+972-54-6543-112
adi@redhillbio.com
|
Media
contacts:
U.S.: Bryan
Gibbs, Finn Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
UK: Amber
Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
[1] Naloxegol Achieved Rapid and Sustained Improvement of
Opioid-Induced Constipation (OIC) Symptoms: A Pooled Analysis of
Two Global Randomized Placebo-Controlled Trials. Chey, William D.;
Rockett, Carol B.; Bortey, Enoch; Almenoff, June.
[2] Rapid Onset of Time to First Spontaneous Bowel Movement
(SBM) and Predictable Efficacy of Naloxegol: Pooled Analysis of Two
Global Randomized Controlled Trials. Chey, William D.; Rockett,
Carol B.; Bortey, Enoch; Almenoff, June.
[3] Crockett, Seth D., et al. American Gastroenterological
Association Institute guideline on the medical management of
opioid-induced constipation, Gastroenterology 156.1 (2019):
218-226.
[4] Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com.
[5] Full prescribing information for Talicia®
(omeprazole magnesium, amoxicillin and rifabutin) is available at:
www.Talicia.com.
[6] Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
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SOURCE RedHill Biopharma Ltd.