PR91508

TEL AVIV, Israel and RALEIGH, N.C., Sept. 7, 2021 /PRNewswire=KYODO JBN/ --

- 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.

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Source:  RedHill Biopharma Ltd.