- Two new analyses of Movantik(R)  (naloxegol) data evaluated the safety and 
efficacy of Movantik in a subgroup of patients aged >/=65 years
- Analysis of Movantik effects on rapid and sustained improvement of both 
spontaneous and complete spontaneous bowel movements in the Movantik group vs. 
placebo were evaluated across high and low opioid dosages 
- Movantik is the U.S. market-leading oral peripherally acting mu-opioid 
receptor antagonist (PAMORA), approved to treat opioid-induced constipation in 
adults with chronic non-cancer pain

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty 
biopharmaceutical company, today announced presentation at PAINWeek 2021 of 
three new analyses of Movantik(R)  (naloxegol) Phase 3 study data demonstrating 
rapid onset of action and sustained and predictable improvement of key symptoms 
associated with opioid-induced constipation (OIC) in both a subgroup of 
patients aged >/=65 and across both low and high dose opioid therapy. 

Two of the posters are dedicated to the subgroup of patients aged >/=65, with 
Movantik achieving significantly better response rates vs. placebo, with rapid 
onset of action and a higher proportion of subjects achieving spontaneous bowel 
movement (SBM) and complete spontaneous bowel movement (CSBM) over the first 48 
hours of treatment. Additional presented data also shows that naloxegol 
delivers similar rapid and sustained symptom improvement for patients, 
irrespective of the opioid dose they are prescribed, including at doses lower 
than 100 mg of morphine equivalent. The authors conclude that even with lower 
doses of morphine equivalent, clinicians should be diligent about treating 
these patients because they still are susceptible to OIC. 

The three 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 446 patients in the placebo arms.  
"With up to 90% of older patients receiving opioids to help cope with chronic 
pain, and up to 86% of them suffering from symptoms of OIC, these new analyses 
are particularly important in helping these patients achieve satisfactory 
control of their pain without the added burden of OIC. Older patients tend to 
be more susceptible to OIC due to comorbidities, polypharmacy, and reduced 
physical activity, and it is vital that they have access to therapies such as 
Movantik, that are shown to be effective in this challenging patient group." 
said Dr. Lynn Webster, Pain Researcher and Clinician and Senior Fellow at the 
Center of U.S. Policy. 

"There has been a shift in clinical practice to try to reduce doses of opioids 
used to treat chronic pain. However, low dose opioid therapy can prove to be 
equally troublesome in terms of treatment-related constipation as higher doses 
and it is important that physicians are diligent in monitoring for signs of 
OIC," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Scientific Officer. 
"This new analysis showing Movantik's efficacy irrespective of opioid dose is 
equally important in supporting the clinical shift to low dose opioid therapy 
through the management of OIC which can be expected in between 40-80% of 
patients taking chronic opioid therapy[1]."

New Movantik (Naloxegol) Analyses Presented at PAINWeek 2021 [ 
https://www.eventscribe.net/2021/PAINWeek/agenda.asp?startdate=1/1/2001&enddate=1/1/2001&BCFO=&pfp=Browse%20by%20Day&tn=&cpf2=&cus2=&pta= 
]: 

Poster 1 (poster number 55): 
Naloxegol Provided Rapid Onset of Time to First Spontaneous Bowel Movement 
(SBM), Complete SBM and Predictable Efficacy in Older Adults (Age >/= 65 Yrs): 
A Pooled Analysis of Two Phase 3 Studies
Authors: Lynn Webster, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, 
Enoch Bortey, Theresa Mallick-Searle, Martin Hale

Poster 2 (poster number 59):
Naloxegol Provided Rapid and Sustained Improvement of Opioid-Induced 
Constipation (OIC)
Symptoms in Older Adults Age >/= 65 Yrs: A Pooled Analysis of Two Phase 3 
Studies
Authors: Martin Hale, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, 
Enoch Bortey, Theresa Mallick-Searle, Lynn Webster

Poster 3 (poster number 30):
Naloxegol Provides Rapid and Sustained Improvement of Opioid-Induced 
Constipation (OIC)
Symptoms Irrespective of Opioid Dose: A Pooled Analysis of Two Phase 3 Studies
Authors: Jeffrey Gudin, Jeremy A. Adler, June Almenoff, Carol B. Rockett, Enoch 
Bortey, Richard Rauck, Lynn Webster

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(R)  for opioid-induced constipation in 
adults[2], Talicia(R)  for the treatment of Helicobacter pylori (H. pylori) 
infection in adults[3], and Aemcolo(R)  for the treatment of travelers' 
diarrhea in adults[4]. 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 global Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer 
and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral 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, 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(R)  (naloxegol)
Movantik(R)  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(R)  (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 [ 
https://movantik.com/pdf/MovantikMedicationGuide.pdf ]and full Prescribing 
Information [ https://movantik.com/pdf/MovantikPrescribingInformation.pdf ]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(R); (v) the Company's ability to 
successfully commercialize and promote Talicia(R), and Aemcolo(R)  and 
Movantik(R); (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] Crockett, Seth D., et al. American Gastroenterological Association 
Institute guideline on the medical management of opioid-induced constipation, 
Gastroenterology 156.1 (2019): 218-226.
[2] Full prescribing information for Movantik(R)  (naloxegol) is available at: 
www.Movantik.com.   
[3] Full prescribing information for Talicia(R) (omeprazole magnesium, 
amoxicillin and rifabutin) is available at: www.Talicia.com.       
[4] Full prescribing information for Aemcolo(R)  (rifamycin) is available at: 
www.Aemcolo.com.
 
Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg 
 
    
Source:  RedHill Biopharma Ltd.