RedHill Biopharma Ltd (RDHL)

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RedHill Presents New Talicia® Data Analyses at Obesity Week 2022

https://finance.yahoo.com/news/redhill-presents-talicia-data-analyses-110000783.html

Talicia's efficacy, in this analysis of pooled data from two Phase 3 studies, was unaffected by presence of diabetes or elevated body mass index (BMI); additionally, pharmacokinetic modeling results indicate that intragastric rifabutin exposure was unaffected by elevated patient BMI

Published data suggest that elevated BMI and presence of diabetes may be associated with the failure of clarithromycin-based H. pylori treatments, further supporting the use of Talicia as a first-line therapy in all populations

Talicia, the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, is an empiric first-line therapy for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population

RALEIGH, N.C. and TEL AVIV, Israel, Nov. 4, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the presentation of new Talicia® data analyses for the treatment of H. pylori, at the Obesity Week Annual Meeting, November 1-4, 2022.

Rates of obesity continue to rise in the US, with over 70% of the population being overweight or obese[1], and understanding the efficacy of antibiotics in this population is paramount. Additionally, obesity is associated with a higher risk of diabetes, which affects over 11% of the overall US population[2]. Published data have shown that both obesity and diabetes have been associated with failure of clarithromycin-based therapies for the treatment of H. pylori infection. Obesity can negatively impact intragastric exposure to key antibiotics used to treat H. pylori and high intragastric exposure is known to be essential for successful eradication. These analyses assessed the safety and efficacy of Talicia in achieving H. pylori eradication in patients who are either obese or have diabetes. Furthermore, Physiologically-Based Pharmacokinetic (PBPK) modeling was used to compare intragastric rifabutin concentrations with Talicia (low-dose rifabutin 50 mg) across different body mass index (BMI) subgroups. Results showed that Talicia was unaffected by presence of diabetes or elevated BMI, with modeling results indicating that intragastric rifabutin exposure was unaffected by patient BMI.

"This work supports that patient diabetic status, body mass index, and race/ethnicity have negligible impact on the high eradication rates achieved with Talicia. This is clinically important given the high prevalence of obesity and of diabetes," said Dr. Dana Portenier, Division Chief, Metabolic and Weight Loss Surgery, Duke University School of Medicine. "Moreover, Talicia was shown to maintain high intragastric rifabutin concentrations regardless of patient obesity status, further supporting its use as a rational choice for empiric first-line therapy."

Poster title: Low-dose Rifabutin (50 mg) Triple Therapy for H. pylori is Efficacious and Well Tolerated in Patients with Obesity or Diabetes

Presenting Author: Dr. Dana Portenier, Division of Metabolic and Weight Loss Surgery, Duke University School of Medicine.

This work builds upon a previous post hoc analysis of phase 3 clinical studies, demonstrating that patient BMI had no statistically significant impact on eradication outcomes with Talicia. PBPK modeling supports minimal differences in intragastric rifabutin concentration time above MIC90 for H. pylori between patients with normal BMI or those who are overweight or obese (approximately 22 hours [93%] of the day across groups).

Additionally, a post hoc analysis of phase 3 clinical studies demonstrated that diabetes had no statistically significant impact on eradication outcomes with Talicia. Furthermore, the safety profile of Talicia in these patients was generally similar to the overall population, and no cases of hypoglycemia were reported. This is clinically relevant as clarithromycin has a risk of drug interactions with commonly used diabetes medications such as insulin and metformin[3], as well as potential for increased risk of hypoglycemia[4]. Furthermore, low-dose rifabutin (50mg Q8H) triple therapy for 14 days produced high eradication rates and displayed favorable safety and tolerability across all subjects.

These data support the efficacy and safety of Talicia as empiric first-line treatment for H. pylori infection in patients regardless of obesity or diabetic status.

About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35%[5] of the U.S. population, with an estimated two million patients treated annually[6]. 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[7] and a major risk factor for peptic ulcer disease[8] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[9]. More than 27,000 Americans are diagnosed with gastric cancer annually[10]. 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[11].