Talicia® Named First-Line for H. pylori in New ACG Guidelines

RedHill Biopharma Ltd. has announced that its drug Talicia has been listed as a first-line treatment option in the new American College of Gastroenterology (ACG) Clinical Guideline for Helicobacter pylori (H. pylori) infection. This marks the first update of the guideline since 2017 and recognizes Talicia's efficacy and convenience without the need for prior resistance testing.

Talicia is an all-in-one formulation combining amoxicillin, rifabutin, and a proton pump inhibitor (PPI) called omeprazole. This combination is taken three times daily with food for 14 days, simplifying the patient's regimen and enhancing compliance. The drug's formulation has demonstrated minimal resistance rates, making it a reliable choice for treating H. pylori. According to Dr. Colin W. Howden, Chief of Gastroenterology at the University of Tennessee Health Science Center, resistance rates for amoxicillin and rifabutin are below 3% and 1% respectively.

Rick D. Scruggs, President of RedHill Biopharma, noted that the updated guideline confirms the use of Talicia as a primary treatment option, giving healthcare providers confidence in its prescription without needing prior resistance checks. The approval of Talicia in the guideline is expected to improve patient outcomes by changing the standard treatment protocol for H. pylori.

H. pylori is a bacterial infection affecting about 35% of the U.S. adult population and around 66% of people worldwide. Classified as a Group 1 carcinogen by the World Health Organization (WHO), it is the strongest known risk factor for gastric cancer and a significant cause of peptic ulcer disease. Despite widespread treatment efforts, current therapies fail in approximately 25-40% of cases due to antibiotic resistance, particularly to clarithromycin, which has traditionally been part of standard treatment regimens.

Introduced in November 2019, Talicia is the only FDA-approved therapy based on low-dose rifabutin for treating H. pylori. In a pivotal Phase 3 study, Talicia demonstrated an 84% eradication rate of H. pylori in the intent-to-treat population, compared to 58% in the active comparator group. For those who adhered to the therapy, the response rate was even higher at 90.3% versus 64.7% in the comparator arm. The study also found minimal to zero resistance to rifabutin.

RedHill Biopharma emphasizes that Talicia should be used only for bacterial infections to avoid the development of drug-resistant bacteria. The medication is contraindicated in patients with hypersensitivity to its components or those taking certain other medications, such as rilpivirine-containing products. Reported adverse reactions include diarrhea, headache, nausea, abdominal pain, and rash among others.

Talicia enjoys eight years of market exclusivity in the U.S. under its Qualified Infectious Disease Product (QIDP) designation and is protected by patents extending until 2034, with additional patents pending in various regions worldwide.

RedHill Biopharma, headquartered in Raleigh, N.C., and Tel-Aviv, Israel, focuses on gastrointestinal and infectious diseases. Besides Talicia, the company markets Aemcolo for travelers' diarrhea and is developing several other drugs targeting conditions including COVID-19, cancer, and gastrointestinal diseases.