RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma Presents New Talicia(R) and Movantik(R) Data Analyses at ACG 2021

https://finance.yahoo.com/news/redhill-biopharma-presents-talicia-r-110200370.html

Two new analyses evaluate pharmacological and clinical advantages of Talicia® as first-line
H. pylori therapy over clarithromycin-based regimens
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Two new analyses of Movantik® data evaluate efficacy in treating extreme opioid-induced constipation with severe symptoms
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Talicia®, an FDA approved therapy, is designed to replace clarithromycin-based regimens as first-line H. pylori eradication therapy; ACG Guideline recommends avoiding treatment with clarithromycin to eradicate H. pylori due to growing bacterial resistance
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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

TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / October 25, 2021 / RedHill Biopharma Ltd.(NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the presentation of four new analyses of Phase 3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] and Movantik® (naloxegol)[2] data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021.

The first Talicia analysis evaluated physician-directed therapy data, confirming high utilization of clarithromycin and low rates of H. pylori eradication. Inappropriate use of clarithromycin persists despite American College of Gastroenterology (ACG) recommendations to avoid clarithromycin when treating H. pylori patients who have a history of macrolide exposure, where local resistance rates are ≥ 15% or unknown, and/or when the patient has been previously treated with a clarithromycin-containing regimen. Utilization data based on U.S. prescriptions confirmed that clarithromycin-based regimens remain predominant, even though the majority of Americans have previously been prescribed a macrolide antibiotic[3]. The authors conclude that since Talicia does not contain clarithromycin, and resistance to amoxicillin and rifabutin is very rare, Talicia can be used first-line with minimal concern for antibiotic resistance or CYP2C19 metabolism.

The second Talicia analysis assessed gastric luminal rifabutin concentrations of three times a day rifabutin 50 mg (the dose of rifabutin within Talicia®) vs. once-daily administration of rifabutin 150 mg, and the potential impact on H. pylori eradication. The data suggest that there may be a link between sustained gastric rifabutin exposure achieved with Talicia's unique dosing and formulation and the 90% eradication rates seen in clinical studies. The findings demonstrate that rifabutin dosed once-daily as 150 mg cannot replicate both the pharmacokinetic profile and therapeutic effects of rifabutin 50 mg three-times daily (as dosed in Talicia®).

"Sustained high intragastric rifabutin concentrations explain the high clinical trial eradication rates seen with Talicia and suggest that three-times daily Talicia should be considered a first-line therapy for patients with H. pylori infection." said Dr. Colin W. Howden, MD, AGAF, FACG, Professor Emeritus, University of Tennessee Health Science Center. "Contrary to ACG guideline recommendations, many physicians continue to prescribe clarithromycin-based therapies to patients, resulting in low rates of eradication because of high rates of clarithromycin resistance."

The two Movantik posters analyzed data from patients experiencing extreme opioid-induced constipation (OIC) with severe symptoms. Both Movantik 12.5 mg and 25 mg provided rapid onset with early symptom relief and consistent, predictable and sustained efficacy in improving multiple symptoms despite high baseline symptom burden. Movantik also demonstrated a favorable safety-profile and tolerability.

The two analyses included pooled data from two large, pivotal 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.

"Chronic pain patients are already subject to considerable suffering. For up to 80% of them, this is compounded by opioid-induced constipation - with a significant number suffering from extreme OIC with severe and debilitating symptoms. Movantik demonstrated both rapid and durable symptom improvement which are highly important clinical considerations in patients with OIC" said Dr. Darren M. Brenner, MD, AGAF, Associate Professor of Medicine and Surgery at Northwestern University Feinberg School of Medicine and Director of the Gastrointestinal Physiology Laboratory and Functional Bowel Programs.

Posters Presented at ACG 2021 Annual Scientific Meeting:

Talicia:

Poster number 2029
RHB-105 Q8H Rifabutin Dosing Provides Favorable Exposure for Helicobacter pylori Eradication
Presenter: Dr. Colin W. Howden
Authors: Colin W. Howden, Salil N. Pendse, Mark A. Bush, June S. Almenoff, Kely L. Sheldon

Poster number 3083
Pitfalls of Physician-Directed Treatment of Helicobacter pylori Infection: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data
Presenter: Dr. Colin W. Howden
Authors: Colin W. Howden, Kely L. Sheldon, June S. Almenoff, William D. Chey

Movantik:

Poster number 0386
Naloxegol Accelerates Time to First Spontaneous Bowel Movement (SBM) and Complete SBM (CSBM) with Predictable Efficacy in Patients with Extreme Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Phase 3 Trials
Presenter: Dr. Darren M. Brenner
Authors: William Chey, Carol B. Rockett, Jeremy Adler, Theresa Mallick-Searle, Enoch Bortey, Darren M. Brenner

Poster number 0397
Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC) Symptoms in Patients with Extreme OIC: A Pooled Analysis of Two Pivotal Phase 3 Trials
Presenter: Dr. Darren M. Brenner
Authors: Darren M. Brenner, Carol B. Rockett, Jeremy Adler, Theresa Mallick-Searle, Enoch Bortey, William Chey

About Talicia®

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 clarithromycin-based therapies. 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[4] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[5].

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. pylori

H. pylori is a bacterial infection that affects approximately 35%[6] of the U.S. population, with an estimated two million patients treated annually[7]. 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[8] and a major risk factor for peptic ulcer disease[9] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[10]. More than 27,000 Americans are diagnosed with gastric cancer annually[11]. 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[12].