Redhill Biopharma Ltd (REDIF) Reports New Talicia and Movantik Data Analyses

RedHill Biopharma Ltd. (Nasdaq: RDHL), 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

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