RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI

https://finance.yahoo.com/news/redhill-biopharma-data-published-gastrohep-120000559.html

High Body Mass Index and obesity are known risk factors for H. Pylori eradication treatment failure; Newly published data in GastroHep shows high eradication rates for Talicia® across BMI groups

Data from a post-hoc analysis showed H. pylori eradication rates with Talicia of 88.1% and 90.9% in patients with BMI> 30/<40kg/m2 and in patients with BMI>40 kg/m2, respectively, versus active comparator rates of 62.9% and 31.8% respectively - an almost 50% difference in efficacy from the active comparator in the severely obese group

Talicia, an FDA approved therapy, may be used as first-line H. pylori eradication therapy

TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announces the publication of a new study entitled "Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index" in the journal GastroHep, showing the high efficacy of Talicia in eradicating H. pylori irrespective of patient BMI and level of obesity in clinical trials.

This new publication, describing a post-hoc analysis of data from 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials who had BMI >30 kg/m2, showed that Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001). Patients with a BMI between 30-40 kg/m2 and those with BMI >40kg/m treated with Talicia achieved eradication rates of approximately 90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively – the active comparator demonstrated nearly 50% lower efficacy in the severely obese group.

"High BMI and obesity are known risk factors for H. Pylori eradication treatment failure[1]. Data from previous studies[2] have shown that the failure rate of clarithromycin triple therapy can increase by nearly 300% in patients with high BMI, from nearly 15% in patients with BMIs<25 kg/m2 to 45% in subjects with BMIs≥25 kg/m2," said Prof. John Yung-Chong Kao, MD, Professor of Internal Medicine, Division of Gastroenterology, University of Michigan, and lead author of the paper. "With more than 70% of American adults being overweight or obese, it is important to understand the influence of patient BMI on H. pylori eradication treatment success. These data support that low-dose rifabutin-containing therapy such as Talicia can be considered as a first line therapy to treat H. pylori infection particularly in patients with high BMI."

No cases of rifabutin resistance were identified in this study, compared to a pooled clarithromycin resistance rate of more than 17% seen across all BMI groups, which highlights the potential risk of empirically prescribing clarithromycin-containing regimens for the treatment of H. pylori. Generally, no differences were identified in the safety of Talicia across BMI groups, consistent with its overall safety profile.

"The obese population experiences more infections and thus has more antibiotic exposure than the general population, potentially leading to higher rates of antibiotic-resistant organisms," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer." Given the medical risks associated with obesity, it is especially important to use highly effective treatments such as Talicia, to provide patients with a high probability of cure with first-line treatment."