RedHill announces start of confirmatory Phase III Study of RHB-105 (Talicia)

RHB-105 Talicia

RHB-105, newly branded as Talicia, a treatment of H. pylori infection, is now undergoing its confirmatory Phase III study, according to specialty biopharmaceutical firm RedHill Biopharma Ltd.

Talicia is a proprietary, fixed-dose, oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule for the eradication of H. pylori infection.

H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infection is estimated to affect over half of the adult population worldwide. The H. Pylori bacteria is showing growing resistance to metronidazole and clarithromycin.

The two-arm, randomized, double-blind, active comparator confirmatory Phase III ERADICATE Hp 2 study will compare Talicia against a dual therapy amoxicillin and omeprazole regimen at equivalent doses.

The study is planned to enroll 444 non-investigated dyspepsia patients with confirmed H. pylori infection in up to 65 clinical sites in the United States.

Subjects will be randomized in a 1:1 ratio to receive four capsules, three times daily, of either Talicia or the active comparator, for a period of 14 days. Subjects will be assessed for the study’s primary endpoint of eradication of H. pylori infection at 42 through 70 days after initiation of treatment.

The first Phase III study with Talicia successfully met its protocol-defined mITT primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70 per cent with high statistical significance (p<0.001), according to RedHill.

The study results demonstrated 89.4 per cent efficacy in eradicating H. pylori infection with Talicia. This result was also “superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated 63 per cent eradication rate in the mITT population (p=0.006),” according to the company.

The 2015 global and U.S. market potential for H. pylori eradication therapies at branded prices, were estimated at approximately $4.83 billion and $1.45 billion, respectively, according to RedHill.

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