RedHill Biopharma (Nasdaq: RDHL) today announced the presentation of two new data analyses from the Talicia® H. pylori eradication clinical trials program at Digestive Diseases Week (DDW) 2022.
Talicia’s efficacy and safety profile evaluated in patients with H. pylori infection and diabetes mellitus, a large and challenging patient population associated with sub-optimal outcomes with clarithromycin-based H. pylori eradication therapy
Physiologically based pharmacokinetic modeling study of Talicia evaluated intragastric antibiotic exposure, which is critical for successful H. pylori eradication, by comparing low-dose rifabutin 50 mg every 8 hours to the generic formulation of rifabutin 150 mg once a day
Talicia, now the leading FDA-approved brand for H. pylori treatment, is intended for empiric first-line eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population, representing significant unmet need
“More than 37 million Americans have diabetes, which presents significant issues in the treatment of H. pylori infection. Firstly, we know that the risk of treatment failure with clarithromycin-based therapies is significantly higher in patients with diabetes, and secondly, the use of clarithromycin in diabetic patients can impair the management of their diabetes due to drug-drug interactions,” said Dr. Barry Johns, MD, from The Jones Center for Diabetes and Endocrine Wellness, Macon, GA. “Consequently, it is vital that we know which therapies are most appropriate for first-line H. pylori eradication treatment. Since Talicia maintains high eradication rates and is well tolerated regardless of a patient’s diabetes, it represents a rational empiric first-line choice for the treatment of H. pylori infection.”
“Maintaining high intragastric antibiotic concentrations is necessary for successful H. pylori eradication. Dosing rifabutin at 150 mg QD does not replicate the sustained intragastric concentrations predicted with low-dose rifabutin at 50 mg Q8H. The differences in intragastric exposure seen in this study may potentially explain the lower and less consistent eradication rates seen with generic rifabutin (about 70% eradication) than seen in the Talicia clinical trial program (about 84-90% eradication),” said Dr. Colin W. Howden, MD, Professor Emeritus, University of Tennessee Health Science Center. “Given the need to aim for the most effective empiric first-line eradication therapy, it is important to utilize a therapy with the highest likelihood of H. pylori eradication success, such as Talicia.”
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